• Leads the annual financial planning process to develop the annual Plan (Plan, Update, LBE) for gross to net expenses approved by the Parent company, TPC. Works with Director, Commercial Finance in the consolidation of annual Net Sales through Distribution Margin for the Annaul MRP.


• Strategically works with Contracts & Pricing, Business Insights, Marketing director and Finance Brand managers/analysts to drive alignment in decision-making surrounding detailed volume and pricing assumptions required to forecast Net ASP and projected volume by product class of trade.


• Oversee concise and well thought out financial presentations for Plan/Update reviews with senior level management from both parent companies.


• Provide guidance and financial business partnership to senior and other function-level management.


• Ensure all pertinent discount related accounting records and analyses meet the internal/external audit requirements.


• Prepare and review management commentary on monthly operational results for senior management and parent company for total Net Sales as well as discount expense.


• Manage the process and timelines for ad hoc analysis.


• Escalate critical issues to senior management.


• Review work performed by direct reports to ensure accuracy and relevance.


• Provide professional and motivational leadership for employees reporting directly to this position.

• Bachelor's degree in Finance or Accounting, including well-rounded coursework in other disciplines.


• At least 7 years of overall business experience, with a miminum of 3 years in financial planning roles.


• Strong analytical skills with demonstrated business impact in previous leadership roles.


• Strong computer software skills (Microsoft Office Suite - Word, Excel, PowerPoint).

• MBA or CPA


• Experience working in a pharmaceutical or healthcare setting.

• Strategic vision - ability to recognize, forecast and communicate events, which may impact the business.


• Leadership - ability to guide a team in day-to-day and long-term related activities.


• Coach - ability to identify development needs of staff and create a plan to address specific needs.


• Communication - ability to communicate ideas and data both verbally and written, in a persuasive, organized and appropriate manner, including running meetings and preparing presentations for customer groups. Ability to communicate effectively with Senior Management and representatives from Parent Company. Ability to "push back" in a respectful manner and to present "unpopular" ideas and messages when necessary.


• Analytical - ability to analyze financial and investment analyses and understand how to use this information to drive projects that will impact the business. Ability to interpret and question data inputs to financial models and support alternative recommendations as necessary.


• Management - ability to set priorities for a team and meet specific deadlines in a changing environment. Ability to be flexible, accommodating, and to deal with change effectively.


• Customer Service Orientation - ability to gain trust of high-level management and leverage relationships to provide best possible financial plans and drive impactful analytical projects.


• Teamwork - ability to work effectively in and foster a team environment.


• Entrepreneurial - ability and desire to take ownership of activities and projects, desire to shape the organization, consistent "out of the box" thinking.

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).


• Ability to sit for long periods of time.


• Carrying, handling, and reaching for objects.

• Minimal

OBJECTIVE:

Partners with Sales or Marketing leadership to implement and oversee Human Resources strategy, policies and activities within assigned regions and/or home office functional groups. Coaches, influences, and supports functional Vice President, director and manager level Sales or Marketing management in all HR related areas Primary functions include employee relations, compliance, talent acquisition, job description and analysis, organizational development, career path, performance management, compensation administration, change management, communications and training. This position will work closely with Sales or Marketing Management, other Regional HR Managers, Specialists in Human Resources (i.e. Compensation, Talent Acquisition, and Talent Management), in an effort to develop departmental goals, objectives and systems that correspond with the organizational strategy

ACCOUNTABILITIES:

ACCOUNTABILITIES:

• 
  
  Manages system for capturing, evaluating, and tracking potential BD licensing opportunities (i.e., Vertical*I and/or similar databases), working with the S&E team (and others in GLBD as appropriate) to ensure that opportunities, key documents (e.g., CDAs), and milestones are captured and updated in an accurate and timely manner.
  
  
• 
  
  Develops and prepares standardized monthly S&E reports and other standardized and ad hoc BD activity reports (e.g., Triage reviews, CDAs, frequency count- and time-based metrics), extracting relevant data from the BD licensing opportunity database and performing quality control to ensure that S&E reports are high-quality and submitted to the Director/Senior Director, S&E for review within designated timelines.
  
  
• 
  
  Serves as primary administrator for BD licensing opportunity database, managing seat licenses and user access set-up, providing initial training and consultation to global system users, providing operational support for system problem resolution and upgrades, and serving as the first point of contact for vendors and for Takeda IT.
  
  
• 
  
  Sets up and administers collaborative GLBD SharePoint sites to support confidential scientific meetings and Due Diligence for potential BD in-licensing opportunities, global partnering conference activities, and other projects requiring coordinated communication and sharing of confidential documents.
  
  
• 
  
  Participates on global/cross-functional project teams to evaluate and recommend improvements in BD licensing opportunity database (and other related partnering databases), facilitating communication and enhancing operational effectiveness within and across groups.
  
  
• 
  
  Prepares ad hoc reports on BD licensing opportunities and companies using standard BD/pharmaceutical industry databases as requested to support GLBD S&E activities.
  
  
• 
  
  Provides operational support and project management for other GLBD S&E initiatives, as requested by Director/Senior Director, S&E.

• Bachelor’s degree in health sciences, business, database management, or related field
  
• At least 3 years of pharmaceutical or biomedical industry experience

• Advanced degree in database management or project management

• Proficiency in using Microsoft Office tools including Excel, Word, PowerPoint, and project tracking tools is required.
  
• Ability to analyze and aggregate information in varied formats from BD databases and resources.
  
• Ability to manage a variety of simultaneous tasks and priorities, track project progress, identify/resolve project issues (escalating these when appropriate), and drive projects to completion, with limited supervision.
  
• Strong attention to detail.
  
• Ability to interact appropriately and effectively with a variety of global stakeholders, both within GLBD and in other interdependent functions.
  
• Ability to work effectively on cross-functional teams.
  
• Ability to anticipate environmental changes and adapt processes accordingly, seeking input from key stakeholders when appropriate.

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  
• Ability to sit and stand for long periods of time.
  
• Carrying, handling, and reaching for objects.

• Ability to travel to various departmental meetings or conferences on occasion, which may involve limited overnight trips.

• Manages business applications throughout the application lifecycle from initial development through ongoing enhancement.


• Prioritizes business requests and manage demand to ensure a smooth and effective business process flow.


• Conducts strategic planning for application, proactively identifying changes in business and technology landscape that would impact application. Identify technical projects required to maintain service levels.


• Ensures changes to application are aligned and support strategy across TPNA, supporting cost estimates, functional design, solution architecture, technical design, and a successful transition to production (steady-state) environment.


• Ensures policy-compliance and manage software licenses, security certificates, and contracts. Supports design of application roadmap from creation to sunset.


• Consults architects, customers, third party service providers and IT management in design, planning, integration, expansion, problem determination and resolution.


• Serves as primary technical contact for vendors within area of specialization.


• Works closely with respective product vendors to plan upgrades and implementations, evaluate alternative software solutions and to resolve issues.


• Act as the primary IT contact for assigned business units

• Minimum of 4 years SAP functional, configuration and/or development experience with Bachelor’s degree, 8 years SAP functional, configuration and/or development experience with High School diploma.
  
• Minimum 2 years supporting business functions. Specific business knowledge and experience required will vary by position. Examples include: Finance, Human Resources, Supply Chain, Demand Management, and Learning Management.
  
• Strong technical / application development skills.
  
• Project management experience, including management of full lifecycle implementations for major application implementation.
  
• Ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
  
• Ability to analyze a wide variety of data and make appropriate decisions.
  
• Ability to set priorities, develop workflow processes and manage business and provider relationships.
  
• Experience with implementing major third party systems.
  
• Extensive experience with SDLC methodology and the validation process, including writing deliverables for validated systems.
  
• Experience with working with multiple teams across a matrixed organization to implement solutions.

• Pharmaceutical industry and drug development experience.
  
• Takeda Operations – comprehensive understanding of Takeda’s operating structure and methods, including a thorough knowledge of the foreign-owned parent company a plus.
  
• SAP certification within module and/or technology desired.
  
• 
  
  SAP I-Docs experience.
  
  
• 
  
  IBM Sterling Integrator.
  
  
• 
  
  EDI mapping and business process modeling.

• Ability to sit and stand for long periods of time.
  
• Carrying, handling and reaching for objects.
  
• Manual dexterity to operate office equipment i.e. computers, phones, etc.

• Access to transportation to attend various meetings held in proximity to the Takeda offices.
  
• Able to fly to various meetings at investigator, vendor or regulatory agency sites.
  
• Some international travel may be required.

• Administer semi-annual financial planning processes for assigned functional teams, resulting in highly accurate submissions including cost center detail, book page summaries and supporting analyses as required.
  
• Develop financial models and analytical tools to support function objectives and projects.
  
• Support the development and use of financial planning system for assigned functions. Create, leverage and deploy financial models for own use and those of other finance staff. Document models and processes and work to creatively and continuously improve the planning process.
  
• Manage the monthly financial close process including identifying and resolving discrepancies in actual transactions in SAP versus planned activity.
  
• Prepare and post adjusting accounting entries as necessary and maintain monthly balance sheet reconciliations for assigned accounts.
  
• Actively participate in the mid-year and year-end audit by supplying requested materials and information as requested by the external audit firm.
  
• Develop detailed explanation for variances between actual and plan on a monthly basis for assigned functional areas.
  
• Prepare and distribute reporting packages and analyses to assigned functional personnel and/or senior management according to established schedules and special requests. Identify ways to streamline and enhance timely and accurate reports.

• Bachelor's degree in Accounting, Finance or equivalent or in lieu of a degree, must have 8 years of business experience with at least 6 of those years in financial analysis, budgeting, forecasting, or reporting.
  
• Minimum of 2 years of business experience.
  
• Previous budgeting, planning and variance analysis experience.
  
• Demonstrated analytical capability.
  
• Strong computer software skills (Microsoft Office Suite: Word, Excel, PowerPoint).

• Communication: ability to communicate ideas and data both verbally and written, in a persuasive, organized and appropriate manner, and preparing presentations for customer groups.
  
• Analytical: ability to analyze monthly financial results.
  
• Accounting: basic understanding of financial and management accounting principles and practices.
  
• Management: work with manager to set priorities and meet specific deadlines in a changing environment, ability to be flexible, accommodating, and to deal with change effectively.
  
• Customer Service Orientation: ability to gain trust of function management and leverage relationships to provide best possible financial plans.
  
• Teamwork: ability to work effectively in and contribute to a team environment.
  
• Entrepreneurial: ability and desire to take ownership over activities and projects, desire to shape the organization.

• Periodic overnight travel may be required.

• Global Cross-Functional Development Program Role i.e., GPST (US, EU), or GPT (US, EU, Japan): GPST/GPT Leader. Leads team (senior functional managers in Operations, Biometrics, Regulatory, Pharmacovigilance, Clinical Pharmacology, Marketing, etc.) by providing overall direction and scientific expertise, and by managing results from ongoing internal studies and external research to optimize the development strategy and the resultant tactical clinical plans required to support global development of the assigned compounds in the Takeda development portfolio to obtain successful regulatory filing (e.g. CTD), successful commercial launch and life cycle management.
  
• Feasibility Assessment: Lead the creation of the product development plan, including the design of all the clinical studies. Establishes, through the development plan, the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of candidate compound. Lead the recruitment of and communication with clinical opinion leaders during the plan development process.
  
• Project Progress: Anticipates or Identifies project needs and maintains a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements.
  
• High Impact Global Decisions: Monitors and interprets data from ongoing internal and external studies and makes GPT decisions that impacts development such as "go/no go" decisions or modification of development plan or study design that may have a significant impact on timeline or product labeling.
  
• Cross Functional Impact (Effect on scope of other functional areas): Initial work output (Development Strategy, Development Plan and Clinical Protocols) dictates scope, complexity, size and budget of all aspects of a program. Ongoing work output (e.g., critical evaluation of program progress and adjusting accordingly) changes program scope. A significant error in judgment may result in loss of approvability of product.
  
• Works closely and communicates frequently with Clinical Operations and Project Management.
  
• Competitive and Scientific information: TGRD Scientific Content Matter Expert on all scientific and clinical aspects on the assigned compounds to both internal and external audiences. Establishes and maintains strong relationships with key consultants, opinion leaders and key investigators in the therapeutic area(s) relevant to the assigned compounds.
  
• Protocols and Reports: Creates protocol concept (Protocol Synopsis) and oversees full protocol writing. Responsible for overall content of clinical reports.
  
• Responsible for overall content of regulatory submissions such as CTDs as the GPST/GPT leader.
  
• Leads negotiations with regulatory authorities impacting the review and approval process.
  
• Represents Clinical Science in cross functional teams or committees that have global program or functional impact.
  
• Leads the clinical development perspective in due diligence evaluation of external compounds and other development opportunities.
  
• Acts as the medical monitor for the clinical studies.

• MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).

• Phase I - Phase IV/ Biomedical pharmaceutical development clinical research experience preferred.

• Access to transportation to attend various meetings held in proximity to the Takeda offices.
  
• Able to fly to various meetings at investigator, vendor or regulatory agency sites.
  
• Some international travel will be required.

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.

No Phone Calls or Recruiters Please.

The objective of the Head of CMSO Communications is to ensure effective internal and external communications for Takeda’s global research & development (R&D) entities, primarily supporting the Chief Medical and Scientific Officer. This critical role will be has primary responsibility for managing the content and processes of CMSO communications including media relations, special events, and internal, external, and executive communications. This position will collaborate with the Head of CCO Corporate Communications and support TPC’s global Corporate Communications department in areas such as investor relations, global branding, corporate social responsibility, sponsorships, and editing/translation of relevant materials.

ACCOUNTABILITIES:

• 
  
  Create and execute CMSO executive communication platform including participating in the research, creation and execution of communications from Chief Medical and Scientific Officer.
  


• Execute CMSO communications strategy to increase awareness, promote and defend external corporate reputation of Takeda’s R&D organization including affiliated legal entities (ex. TCal). Ensure that all communications are aligned with TPC’s corporate strategies and business objectives.
  
  
• In conjunction with TPC and affiliate communication leads as appropriate, manage CMSO participation in media relations activities in alignment with corporate strategy and communication goals. Provide external communication support for ongoing business activities, partnerships, etc.
  
  
• Create and conduct activities in support of the global corporate branding strategy for all communication purposes.
  
  
• Execute public relations strategy to promote and defend external reputation of Takeda’s R&D activities, including participation in global issues and crisis communications teams.
  
  
• Provide general assistance, as deemed appropriate by the CMSO, to the Chief Medical and Scientific Officer Office team through development and editing of executive speaker presentations and communications. Identify, assess and present appropriate internal and/or external opportunities to Takeda executive team and provide presentation support.
  
  
• Ensure readiness of the CMSO to effectively serve as a spokesperson for appropriate issues and to effectively respond to internal and external communication issues and opportunities.
  
  
• Serve as the primary point of contact to align all internal and external communication activities and reviews for the CMSO organization including:
  
  
  
  • Division heads of the CMSO organization including PRD, PDD, CMC and IP, Vaccine Business Unit, TAL’s, NFS and CMSOO
    
  
  
• Serve as point person for CMSO investor relations (IR) activities in conjunction with local affiliate communication contacts. Develop IR communication materials in support of Takeda’s IR strategy set by TPC global corporate communications department.
  
  
• Create appropriate CMSO communication plans and processes.
  
  
• Serve as primary media/analyst knowledge manager for CMSO organization by creating strong relationships with international affiliates and continuously researching and reporting industry activities of peer companies.

EDUCATION, EXPERIENCE AND SKILLS:

• 
  
  Bachelor’s degree required; advanced degree preferred.
  
  
  
• A minimum of ten years of professional experience required at a corporation or consultancy with expertise in corporate (internal/external), executive and/or international communications. Scientific communication experience, as well as public relations experience, not required but preferred.
  
  
• Strong written and verbal communication skills required as well as strong interpersonal skills.
  
  
• Ability to manage and lead a team important.
  
  
• Strategic planning and results oriented execution needed.
  
  
• Ability to negotiate and form consensus among various parties important.
  
  
• English/Japanese bilingual language skills preferred.

50% Travel - Mostly International

• Support the Head of the Vaccine Business Division in key activities necessary to launch Takeda’s global vaccine business


• Support VBD’s strategy development process, by serving as a thought partner and internal critic, managing relevant external resources, soliciting input from key stakeholders within and outside of Takeda, and helping to revise the strategy throughout its execution.


• Serve as a liaison to other divisions as needed, helping to ensure strong communication and collaboration across Takeda’s vaccine enterprise.


• Manage high-priority special projects on behalf of the Head, VBD


• Ensure that key initiatives in support of Takeda’s global vaccine business, including those that are linked to KPIs, are on track, intervening as appropriate when they are not on track.


• Ensure follow-through on VBD’s commitments to senior management and key partners outside of the company.


• Serve as an advisor to the Head, VBD, on all dimensions of the business.


• Assist the Head, VBD in triaging and managing critical issues that affect the functioning of VBD as they arise, acting on behalf of the Head, VBD in certain cases as appropriate.

• Strong background in strategy development, management and project management


• Graduate degree in a relevant field necessary, MBA desirable,


• At least 10 years of experience in healthcare


• Strong communication, strategic, analytical problem-solving & interpersonal skills

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).

• Willingness to travel to various meetings including international travel is required.


• Requires approximately 30-50% travel.

• Develop detailed financial models in support of a given project by working with various R&D and Commercial groups to gather inputs.


• Assess actual project spend and commercial results against prior forecasts to provide risk analogs for financial models.


• Capture relevant assumptions behind model inputs to ensure consistency across project iterations.


• Development of project alternative scenarios based upon varying model inputs to capture the range of project outcomes for risk assessment.


• Guide the discussion of the GPTs to fully inform the financial assessment of projects under consideration and to frame GPT decisions in the appropriate financial framework for the given project.


• Inform the GPT on the project’s impact to the overall therapeutic area portfolio.


• Deliver project assessments into a therapeutic area rollups for TAL consideration and further evaluation. Act as the project content expert into the TAL.

Lead, design & manage development of Excel based project evaluation models, coordinating across the TAS team and the BE team in Japan. Work to ensure model coherence and efficiency in support of project evaluations. Contribute to the active sharing of project evaluation knowledge across the US TAS and Japan BE groups to ensure a unified approach to project evaluation across Takeda.

Develop and maintain general therapeutic expertise for assigned therapeutic areas. Develop a detailed understanding of the competitive scientific and commercial landscape in terms of pipelines, payors and prescribers through discussions with GPT members and other resources within Takeda.

Assit with guidance to TALs in terms of P&L consolidation across the therapeutic area, indicification of strengths, weaknesses and oppurtunities, strategic activities to strengthen therapeutic area, and BD augmentation of the therapeutic area.

• Bachelor’s Degree in science or business
  
• Advanced degree preferred
  
• Minimum of 10 years of drug industry experience, in Clinical Research, Regulatory, Development, Commercial, Finance or IT function.
  
• A minimum of 5 years people management experience, and/or a minimum of 8 years experience leading global, cross-functional teams in a matrix environment.
  
• Broad healthcare and/or pharmaceutical business exposure highly preferred
  
• Advanced Excel skills required

• Industry knowledge – solid understanding of the pharmaceutical industry, including drug development process, global healthcare system, prescription drug distribution process (e.g. medical referrals, managed care systems, reference pricing system) etc.
  
• Therapeutic knowledge – an in-depth understanding of the disease state, treatment paradigms and future trends
  
• Product knowledge – comprehensive understanding of the medical /therapeutic usage of the products
  
• Scientific knowledge – solid understanding of disease pathophysiology, associated mechanisms of action, interpretation of basic pre-clinical and clinical data, etc.
  
• Proven leadership skills, conceptual thinking and strategic problem-solving ability
  
• Demonstrated ability to clearly communicate/present key information to senior management
  
• Proactive ability to predict issues and problem solving abilities
  
• Ability to articulate and establish processes which impact cross-functionally
  
• Ability to drive decision-making within a cross-functional and cross-cultural, global team structure
  
• Issue identification and independent resolution
  
• Strong communications skills – written and verbal
  
• Management of multiple tasks of varied complexity simultaneously
  
• Excellent organizational skills
  
• Negotiation and strong persuasive abilities
  
• Diplomacy and positive influencing abilities in a matrix management environment
  
• Presentation skills with appropriate messaging and focused recommendations
  
• Microsoft Project Professional, Excel, PowerPoint & Word

• Valid driver’s license & passport

• Develop integrated publication strategies detailing the appropriate scientific communication for marketed and investigational products within the portfolio


• Coordinates the publication plans for portfolio compounds area to identify potential for collaboration and resource sharing; impact of messaging across compounds; and to maximize data effect at selected venues for the portfolio of compounds.


• Contribute to the globally integrated publication strategies for portfolio compounds.


• Interact directly with Clinical, Statistics, Regulatory Affairs, Marketing, and Medical Affairs to understand communication objectives for the therapeutic area and develop appropriate scientific communications.


• Responsible for publication activities considered to have significant global implications.


• Manages a team of Strategic Publication managers, as well writers and editors without a manager.


• Review manuscripts, abstracts, and poster content as appropriate.


• Attends review meetings, conferences, symposia or other meetings as necessary or as assigned and act as liaison between Strategic Publications and external content contributors.


• Determines appropriate staffing level to adequately cover needed activities, and ensure appropriate balance between resources and activities.


• Manages Strategic Publications budget for the therapeutic area.


• Determines need for, timing of, and content of publication advisory boards.

• Bachelors Degree
  
• 5 years of publications planning experience within the pharmaceutical industry including submission processes for publications, or directly transferable skills
  
• 3-5 years of managing people
  
• Significant project management experience
  
• Pharmaceutical or biomedical writing experience
  
• Experience with peer-reviewed scientific publications
  
• Effectively work with and lead cross functional teams
  
• Excellent written and oral communication skills

• Masters' degree, preferably in a scientific discipline, or sufficient applicable experience
  
• Working knowledge of therapeutic area
  
• Working knowledge of pharmaceutical clinical development and product life-cycle management
  
• Significant experience and knowledge of clinical trial reports, data presentation, and interpretation

• Plan, identify, develop and produce promotional materials needed to support the brands efforts/strategies.
  
• Actively contribute to the annual brand planning and budgeting process.
  
• Development and progression of the Brand message.
  
• Help organize Life Cycle Management activities for the Brand.
  
• Provide strategic guidance to MAR for research in support of the brand.
  
• Establish critical relationships with top opinion leaders and associations in the Brands marketplace.
  
• Direct strategic intent and development of content for advisory board meetings.
  
• Understands processes related to project management and review approval of promotional materials
  
• Interface with Sales, MS&A, Regulatory and Legal, advertising agency, med ed agency and other vendors to create pieces and see them through the approval process.
  
• Capture information from the sales organization to ensure corporate marketing plans and sales activities coincide.
  
• Recommends changes to and manages project budget appropriately with direction from Senior Product Manager. Understands the impact of sales and budget decisions on the P&L statement.
  
• Execute major programs to meet sales and market share objectives
  
• Collaboration with sales and training department on the execution of messages developed to enhance sales calls and product promotion.
  
• Manage suppliers and vendors relative to completion of project tasks and assists with strategy development
  
• Able to prepare and deliver appropriate presentations to a broad and varied audience
  
• Understands and complies with medical and regulatory guidelines for promotional practices
  
• Understands the need to work with R&D to enhance product offerings or pipeline relative to the business units focus
  
• Monitor competitive activity and develop the appropriate tactics to respond to varied threats or opportunities
  
• Collaborate with market research in the development of research strategies and tactics, such as questionnaire focus and development
  
• Manage projects and problem situations to meet tight deadlines and manage expectations
  
• Understand how marketing strategy when designed and implemented properly can lead to competitive advantage
  
• Has the ability to extract new meaning/approaches from existing resources
  
• If person has a direct or indirect staff, responsible for direction and execution of all activities.
  
• Serves as back-up for Senior Product Manager at various meetings.

• Bachelor's degree.
  
• 5 years experience in sales, marketing or related function.
  
• Pharmaceutical industry experience.

• MBA

• Industry Knowledge-understanding of the pharmaceutical industry.
  
• Therapeutic Knowledge - ability to quickly learn the disease state.
  
• Product Knowledge-ability to quickly learn the product.
  
• Management-ability to set priorities, develop workflow processes, and direct people as necessary.
  
• Communication-ability to communicate ideas, data both verbally and written, in a persuasive and appropriate manner.
  
• Budgeting-ability to maintain an accurate budget for product expenses.

• Ability to drive to or fly to various meetings/client sites. Some international travel may be required.

EDUCATION, EXPERIENCE AND SKILLS:

• Manage development of budget components (function-level, product-level, etc.) assigned. Review cost-center level proposals with direct reports and senior management of other functions to facilitate ultimate submission. Instruct design of submission documents to clearly convey budget requests.
  
• Ensure forecasts are updated on regular basis throughout the year (usually four times to include Plan, Update and LBE’s). Escalate critical issues to senior management.
  
• Provide financial support and monthly budget to actual variances and trend reports to various function heads, including relevant comments.
  
• Prepare and review management commentary on Compound results for senior management and parent company.
  
• Assist in determining reporting requirements for management.

• Assist executives in developing long-term vision or strategy of TGRD by providing relevant and requested analyses and forecasts.
  
• Manage the creation of the Strategic Plan submitted to parent company and ensure the accuracy and completeness of the contents.
  
• Assist in development of Key Performance Indicators to be monitored by management.
  
• Assist in developing strategically relevant financial plan and forecast processes for TGRD.

• Perform and/or review pro-forma/ad-hoc analyses and evaluations in support of business investment proposals. Analyses may include items such as:
  
• 
  
  
  
  • Compound spend analysis by Phase
    
  • Integration efforts into TGRD clinical and budget systems
    
  • Capital Spending
    
  • Insource/outsource analysis
  
  
• Manage development and review of feasibility analysis for compounds in S1 development pipeline as directed by Corporate.
  
• Manage development and review of financial support for Business Development opportunities. Includes analysis of a Compound’s financial costing assumptions.

• Provide guidance and financial business partnership to senior and other function-level management (both in US and EU regions).
  
• Assume leadership role in fostering the Takeda culture in department including employee development, teambuilding, and responsiveness to employee issues and concerns.

• Bachelor’s degree in Finance or Accounting, including well-rounded coursework in other disciplines.
  
• At least 10 years of overall business experience, with a minimum of 5 years in financial planning and analysis roles.
  
• At least 2 years of experience in managing Senior Analyst level direct reports.
  
• Strong analytical skills with demonstrated business impact in previous leadership roles.
  
• Proven ability to determine financial and business valuations of investment initiatives.
  
• Strong computer software skills (Microsoft Office Suite – Word, Excel, PowerPoint).

• MBA or MS in Finance or Accounting.
  
• CPA
  
• Experience working in a pharmaceutical or healthcare setting.
  
• Product valuation experience should include understanding of sales forecasting at the “building block” level and ability to lead the process of cost estimation for each element of the product income statement.

• Strategic vision – ability to recognize, forecast and communicate events, which may impact the business.
  
• Leadership – ability to guide a team in day-to-day and long-term related activities.
  
• Coach – ability to identify development needs of staff and create a plan to address specific needs.
  
• Communication – ability to communicate ideas and data both verbally and written, in a persuasive, organized and appropriate manner, including running meetings and preparing presentations for customer groups. Ability to communicate effectively with Senior Management and representatives from Parent Company. Ability to “push back” in a respectful manner and to present “unpopular” ideas and messages when necessary.
  
• Analytical – ability to analyze financial and investment analyses and understand how to use this information to drive projects that will impact the business. Ability to interpret and question data inputs to financial models and support alternative recommendations as necessary.
  
• Management – ability to set priorities for a team and meet specific deadlines in a changing environment. Ability to be flexible, accommodating, and to deal with change effectively.
  
• Customer Service Orientation – ability to gain trust of high-level management and leverage relationships to provide best possible financial plans and drive impactful analytical projects.
  
• Teamwork – ability to work effectively in and foster a team environment.
  
• Entrepreneurial – ability and desire to take ownership of activities and projects, desire to shape the organization, consistent “out of the box” thinking.

• Ability to drive to or fly to various meetings/client sites. Some international travel may be required.
  
• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  
• Ability to sit for long periods of time.
  
• Carrying, handling, and reaching for objects.

• Lead and manage team of Pharmacovigilance Specialists to ensure effective pharmacovigilance project support for development and/or marketed products.
  
• Contribute and assist in high level pharmacovigilance activities including risk/benefit and regulatory activities and interactions
  
• Provides pharmacovigilance functional area expertise and support for assigned developmental and/or marketed products in conjunction with pharmacovigilance physicians.

• Management of Pharmacovigilance Specialists including career development, performance appraisal and assisting in recruitment and retention.
  
• Management of project activities, time lines, deliverables, and resources for assigned compounds
  
• Assignment of projects to ensure effective distribution and use of team resources.
  
• Input into strategic planning and development of departmental procedures.
  
• Mentoring and training for Pharmacovigilance Specialists
  
• Identification and appropriate escalation of issues within team or department to senior management.
  
• Represent pharmacovigilance department internally and external, including interfacing with regulatory authorities, in an effective and professional manner
  
• Provide technical advice and guidance to Pharmacovigilance Specialists to support complex output review activities.
  
• In conjunction with pharmacovigilance physicians, provide input, including data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators.
  
• As required lead the risk/benefit activities including pharmacoepidemiology review, clinical and safety database analyses, literature review and providing analysis of results.
  
• Perform due diligence from a safety perspective on compounds considered for in-licensing.
  
• 
  
  Establish and maintain key metrics for PV activities.
  
  
• 
  
  
  

  Any othertasks assigned by supervisor to assist in departmental activities.

• Bachelor's degree required; scientific/medical field preferred.
  
• Minimum 6 years of experience in healthcare, clinical or pharmacovigilance related including a minimum of 4 years in clinical monitoring, safety or pharmacovigilance.
  
• Demonstrated ability in people management/supervision
  
• Demonstrated skills in effective team building, negotiation and consensus decision making
  
• Excellent databases skills including ability to perform advanced searches and understanding of data mining methodologies
  
• Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis and broad working knowledge of global regulatory requirements.
  
• Critical thinking and analytical skills and ability to make high level decisions
  
• Ability to review, analyze, interpret and present complex data to a high standard
  
• Understanding Takeda business needs with global business perspective and professional attitude.
  
• Good level of computer literacy with Microsoft applications
  
• Excellent organization skills and ability to prioritize individual and team work loads.
  
• Excellent written and oral communication skills including ability to present to large internal/external groups

• Routine demands of an office-based environment.

• Estimated 5-10 times per year outside the area including possible international travel.

• Teams with all Global TGRD functions to ensure studies and programs are delivered on time, within budget, and with a high quality outcome.
  
• Establishes and maintains strong working relationships with clinical research sites, consultants, and service suppliers.
  
• Serves as a primary contact to address contract questions, identify and resolve performance issues. Teams with Global TGRD functions in resolving and/or escalating issues, as applicable.
  
• Teams with Outsourcing management leadership in the development of operational processes which support clinical research site, consulting, and supplier services contracts.
  
• Ensures that contract management activities are in compliance with corporate policies and procedures. Provides reports to Global leadership and presents updates at team meetings.
  
• Educate and guide internal and external global stakeholders on the role of Outsourcing Management and required procedures.

• Manages the negotiation, analysis, review, preparation, and execution of clinical research site, consulting, and supplier services contracts.
  
• Directs the clinical research study budget development, review, negotiation, and execution process. Collaborates with Clinical Operations to finalize clinical research study budgets.
  
• Analyzes supplier services and consultant budgets and proposals to identify value opportunities and negotiates best outcome.
  
• Manages the Request for Proposals, project work order, task order, and change order process to ensure accuracy, completeness, and suitability of pricing.
  
• Collaborates with Legal in developing MSA, clinical research site, and consulting agreements. Analyzes contract language, related to business terms, to ensure protection of the Company.
  
• Liases with Law Department and external contracting parties to resolve contract-related legal issues.
  
• Ensures all contracts have been uploaded and executed in the contract management system.
  
• Oversees the archiving of clinical research site, consulting, and supplier services agreements according to established guidelines and SOP’s.

• Bachelor’s degree and five (5) years experience in outsourcing or related function in pharmaceutical or CRO industry with a minimum of four (4) years direct experience in managing and negotiating outsourced services and contracts.

• Ability to foster teamwork by actively participating in and supporting an environment that cultivates professional growth and organizational effectiveness.
  
• Strong problem-solving, organizational, analytical, negotiation and presentation abilities.
  
• Ability to adapt, prioritize and work as a team member and as a subject matter expert in a cross-functional team environment.
  
• Demonstrated ability to analyze budgets and proposals to identify value opportunities and negotiate best outcomes.
  
• Ability to understand and analyze complex data, identify issues, and implement corrective actions.
  
• Proven ability to communicate (both written and verbally) ideas and data and collaborate effectively.
  
• Strong working knowledge of outsourcing policies, standards, and procedures.
  
• Proven ability to support change management.
  
• Strong attention to detail.
  
• Ensure self-proficiency on new processes, technologies and systems.
  
• Demonstrated understanding of the pharmaceutical industry and the drug development process; including FDA and ICH regulations and industry standards.
  
• Demonstrated aptitude in the use of word processing, spreadsheet, presentation, and Contract Management software.

• 10%

• Develop and implement communications messages and activities that leverage marketplace opportunities to advance and promote a specific brand or group of brands across multiple therapeutic areas and to support future expectations for life-cycle management, both commercially and medically/scientifically.
  
• Participate in strategic planning and be responsible for development and delivery of messages related to pre- and post-launch milestone activities, such as building brand, scientific and therapeutic area awareness with media, key professional disease-state experts and organizations and overall marketplace.
  
• Partner with members of Corporate Communications team to identify initiatives in support of internal communication strategies. Develop and implement messages to build awareness of Takeda brands and corporate direction with key employee audience(s) and ensure alignment of Takeda messaging.
  
• Develop communication materials and ensure corporate/brand messages are aligned across multiple communications vehicles, such as press releases, standby statements, speeches, internal communications and reports.
  
• Participate in Takeda Ambassador Program activities and continued network development in collaboration with team and partner agency.
  
• Advise and prepare executive staff, external and internal disease state experts and brand directors to effectively respond to product-specific communication and media requests, including media training.
  
• Manage partner agencies/external vendor relationships to ensure deliverables are aligned with brand strategic approach and to optimize resources to best achieve ROI within budget.
  
• Monitor brand public relations expenditures and ensure overall spend is within approved budget allocations.

• Minimum of five years experience required, with an undergraduate or graduate degree in journalism, marketing or communications.
  
• Excellent written and oral communications skills required.
  
• Knowledge of health care industry and previous PR management of a pharmaceutical product or product line strongly desired.
  
• Strong project management skills with high attention to detail and the ability to manage multiple ongoing activities simultaneously
  
• Energetic, self-starter and resourceful problem solver

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  
• Carrying, handling and reaching for objects.
  
• Ability to sit or stand for long periods of time while traveling.

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  
• Requires approximately 20% travel.

• Global Cross-Functional Development Program Role i.e., GPST (US, EU), or GPT (US, EU, Japan): GPST/GPT Leader. Leads team (senior functional managers in Operations, Biometrics, Regulatory, Pharmacovigilance, Clinical Pharmacology, Marketing, etc.) by providing overall direction and scientific expertise, and by managing results from ongoing internal studies and external research to optimize the development strategy and the resultant tactical clinical plans required to support global development of the assigned compounds in the Takeda development portfolio to obtain successful regulatory filing (e.g. CTD), successful commercial launch and life cycle management.
  
• Feasibility Assessment: Lead the creation of the product development plan, including the design of all the clinical studies. Establishes, through the development plan, the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of candidate compound. Lead the recruitment of and communication with clinical opinion leaders during the plan development process.
  
• Project Progress: Anticipates or Identifies project needs and maintains a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements.
  
• High Impact Global Decisions: Monitors and interprets data from ongoing internal and external studies and makes GPT decisions that impacts development such as "go/no go" decisions or modification of development plan or study design that may have a significant impact on timeline or product labeling.
  
• Cross Functional Impact (Effect on scope of other functional areas): Initial work output (Development Strategy, Development Plan and Clinical Protocols) dictates scope, complexity, size and budget of all aspects of a program. Ongoing work output (e.g., critical evaluation of program progress and adjusting accordingly) changes program scope. A significant error in judgment may result in loss of approvability of product.
  
• Works closely and communicates frequently with Clinical Operations and Project Management.
  
• Competitive and Scientific information: TGRD Scientific Content Matter Expert on all scientific and clinical aspects on the assigned compounds to both internal and external audiences. Establishes and maintains strong relationships with key consultants, opinion leaders and key investigators in the therapeutic area(s) relevant to the assigned compounds.
  
• Protocols and Reports: Creates protocol concept (Protocol Synopsis) and oversees full protocol writing. Responsible for overall content of clinical reports.
  
• Responsible for overall content of regulatory submissions such as CTDs as the GPST/GPT leader.
  
• Leads negotiations with regulatory authorities impacting the review and approval process.
  
• Represents Clinical Science in cross functional teams or committees that have global program or functional impact.
  
• Leads the clinical development perspective in due diligence evaluation of external compounds and other development opportunities.
  
• Acts as the medical monitor for the clinical studies.

• MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).

• Phase I - Phase IV/ Biomedical pharmaceutical development clinical research experience preferred.

• Access to transportation to attend various meetings held in proximity to the Takeda offices.
  
• Able to fly to various meetings at investigator, vendor or regulatory agency sites.
  
• Some international travel will be required.

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.

No Phone Calls or Recruiters Please.

• Responsible for the execution of Phase II-IV and other approved US and ex-US clinical studies, according to ICH-GCP and required regional regulations as applicable in support of the clinical strategies defined in the Takeda Integrated Development Plan (IDP)
  
• Responsible for the overall management of assigned study conduct, including oversight of the CRO and all other clinical vendors.

• Manage full scope of study conduct ensuring studies are conducted according to the Code of federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and Takeda SOPs
  
• Member of the Regional Study Team, coordinating cross-functional efforts of Trial Operations Management, Site Operations, Analytical Sciences, Pharmacovigilance and all other appropriate functional departments to achieve study objectives and goals
  
• Collaborates with all relevant groups (Trial Operations Management, Site Operations, Clinical Sciences, Analytical Sciences etc) to develop and manage clinical project timelines
  
• Coordinates meetings with study team members as appropriate for the project. Disseminates clinical project communication to all functional groups as appropriate
  
• Contributes to protocol synopsis development and Clinical Operations feasibility assessments
  
• Writing of study protocols, amendments and administrative changes based on approved protocol synopsis, in collaboration with Clinical Program Manager and other cross functional groups
  
• Participation in the selection of CRO and all clinical vendors for assigned studies.
  
• For studies outsourced to a CRO, may work with Trial Operations Management to ensure adequate evaluation by the CRO of study investigators
  
• Provides oversight of vendors which includes communicating expectations and timelines, ensuring deliverables are on time, with no quality issues.
  
• Identify resource issues with external providers and escalate issues to Clinical Program Manager
  
• Planning and participation in investigator meetings in collaboration with all cross-functional team members
  
• Ensure training of all cross-functional team members and vendors on the protocol and expectations of the study
  
• Responsible for managing assigned studies within budget; provides latest best estimate of study budget and provides guidance to Clinical Program Manager on changes to study budget
  
• Responsible for identifying vendor issues and bringing to the attention of the Clinical Program Manager for discussion. Provides input to problem-solving and implements corrective action plan when necessary
  
• Partners with Trial Operations Management and CRO, where applicable, to resolve site issues
  
• Partners with Trial Operations Management and/or vendors for resolution of corrective actions as a result of QA audit and/or regulatory inspections
  
• Escalate issues relevant to medical personnel as appropriate for medical monitoring, safety, and exemptions/deviations
  
• Maintain project tracking system with current study status and provide accurate progress reports on assigned studies as requested
  
• Collaborate with clinical supplies to ensure appropriate and timely drug supply for assigned studies
  
• Review and input to Clinical Study Report
  
• May participate in Clinical Operations initiatives to enhance processes

• Bachelor’s degree or RN required; MS, PharmD, or PhD preferred
  
• Minimum of three years experience in clinical research. CRA experience and practical experience in protocol development (study design) and a good understanding of the operational execution of clinical protocols
  
• Good comprehension of drug development and clinical trial methodology
  
• Good understanding of GCP/ICH/FDA requirements and an ability to assess compliance to these guidelines
  
• Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings etc)
  
• Must exercise good judgment to maintain confidentiality and ensure integrity of data
  
• Must work effectively in a matrix team environment and be flexible to contribute to the needs of the group

• Communication skills- ability to be clear, direct, and tactful when communicating
  
• Basic business and medical writing skills required for protocols amendments, study summaries, and progress reports.
  
• Ability to organize and manage multiple vendors participating in clinical studies
  
• Ability to prioritize work effectively to meet timelines
  
• Budget Management – ability to develop an study budget to monitor and control expenditures; provides justification/rationale for budget variances
  
• Demonstrates basic presentation skills at Investigator or team meetings
  
• Analytical skills – ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem. Responsible for resolving issues with study conduct with appropriate staff and CRO for a clinical study. Good judgment, professionalism and independence are needed in interfacing with staff, CROs, study coordinators, and investigators
  
• Technical Competency - displays in-depth knowledge of clinical study procedures and maintains an awareness of environment as it affects clinical study execution
  
• Ability to provide input to managing external vendor resources related to study conduct

PHYSICAL DEMANDS:

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.

No Phone Calls or Recruiters Please.

• identify and apply emerging technologies and industry best practice
  
• globalize and standardize PDD’s technology strategy and solutions
  
• optimize the global application and user support strategies for PDD

• BS/BA degree required; advanced technical degree preferred (e.g., Computer Information Systems, Management Information Systems)
  
• 10+ years of applicable informatics, systems, and/or relevant drug development operational experience, global experience preferred
  
• 5+ years of line management experience
  
• Strong proven leadership and project management experience, including management of full lifecycle implementations for major applications
  
• Ability to develop and evaluate business cases and effectively manage budgets
  
• Ability to manage large and global change agendas
  
• Ability to assess issues/risks and effectively implement remediation measures
  
• In-depth understanding of web technology and distributed computing.
  
• In-depth understanding of concepts in information management (i.e. relational databases)
  
• In-depth understanding and knowledge of development operating processes
  
• Experience operating in a multi-disciplinary environment, including international exposure
  
• Experience working within a complex organization and demonstrated ability to work across functions and regions, at all levels without direct authority
  
• Knowledge of existing and emerging regulations and industry interpretations to ensure compliance while reducing complexity
  
• Understanding of and ability to analyze and summarize complex, technical information
  
• Ability to influence and work effectively with various business partnerships, regions, and cultures
  
• Excellent communicator with strong written and verbal presentation skills

• Leads projects and provides expertise to increase quality of managed markets analytical and reporting systems.
  
• Performs ad hoc report builds, extracts and presentations as required by MM Management.
  
• Manages projects pertaining to the delivery of business solutions including report design, report testing, report deployment, data validation and report documentation. Conducts as needed any managed care data investigations.
  
• Directs efforts with IT to ensure MM systems and applications perform at optimal levels. Assures MM end user acceptance.
  
• Provides day to day operational assistance and support to MM Account Managers.
  
• Partners with Business Insights Commercial Reporting in ensuring standard payer and product hierarchy rules are followed.
  
• Responsible for either building or working with IT, reports for the Federal and Hospital channels using data from the VA, DOD and IMS DDD or any other vendors.
  
• Leads in the operational support of the MACS and Aggregate spend initiatives from a managed markets perspective.
  
• Provides operational support to the Account Strategy Managers in building any ad hoc extracts, proclarity cubes, enhancements to the business case template.
  
• Supports pipeline product launches by building SAS data set extracts for ad hoc managed markets and managed markets marketing initiatives.
  
• Responsible for developing and overseeing a standardized monthly process for MM reports delivery.
  
• Able to manage multiple projects and timelines simultaneously.
  
• Works directly with vendors to drive projects and produce quality deliverables.
  
• Other duties as assigned.

• Bachelors Degree
  
• 2+ years experience in developing reports/analytics focused on one or more of these areas - Managed Care, Formulary Systems, Pricing and Reimbursement in a pharmaceutical environment
  
• 5+ years of programming experience and an understanding of IT systems and systems development
  
• 2+ years experience in project management
  
• Expertise in one or more coding techniques such as SAS, VBA, SQL
  
• Proficiency with Microsoft Office suite (e.g., Word, Excel, PowerPoint and Access)
  
• Excellent communication and presentation skills
  
• Comprehensive knowledge and experience in translating business requests into actionable technical requirements

• Exposure to Business Intelligence Tools (such as COGNOS, Microsoft Proclarity etc), Managed Care data and reporting using 3^rd party data from IMS, WKH, SDI etc.
  
• Experience in Managed Markets Analytics or Sales operations

• Consistent phone and other (email, meetings) communication methods.
  
• Utilizes a semi-complex records management software and a variety of data processing and excel spreadsheet programs.
  
• Organization and filing of data.

• Understands Takeda's operating structure and methods.
  
• Understands the pharmaceutical industry and the prescription drug distribution process.
  
• 
  
  Familiar with Windows programs and proficient with assorted computer applications.
  
  
• 
  
  Able to make correct decisions in an autonomous environment.
  
  
• 
  
  Able to communicate ideas and data both verbally and written in a persuasive and appropriate manner to all levels of the organization.
  
  
• Able to retrieve, add, update and delete information from a computer system for extended periods of time while maintaining attention to detail and accuracy.
  
• 
  
  Able to work with others and contribute to accomplishing departmental goals.
  
  
• 
  
  Able to prepare and present presentations.
  
  
• 
  
  Proven ability to manage projects that impact different departments.

The overall purpose of this role is to drive growth and innovation in Takeda's vaccines business from external sources via in-licensing of new compounds, product acquisitions, alliances, co-promotion agreements and joint ventures. The role reports to both the EVP of GLBD and the Head Vaccines Business Division and is based in Takeda's US headquarters in Deerfield, IL.

ACCOUNTABILITIES:

Be co-located and serve as a member of the Vaccine Business Division (VBD) team, and execute the following responsibilities in close coordination with both GLBD and the Vaccine Division:

• Coordinate the development of a vaccine Business Development strategy and priorities in alignment with the overall vaccine strategy and Takeda's overall BD strategy
  
• Work with colleagues in VBD to identify targets, research collaboration and licensing opportunities in line with above strategy
  
• Coordinate evaluation of opportunities bringing together and integrating scientific, technical, commercial and financial aspects
  
• Prepare and present vaccine deal proposal to BDLC, MOC and BOD for approval, as required by Takeda decision making process
  
• Lead partnering negotiations collaborating as necessary, additional members of GLBD on more complex transactions (e.g. M&A, JVs)
  
• Serve as a liaison for academic and other research collaborations
  
• Serve as a senior alliance manager to on-going collaborations
  
• Manage two additional Business Development professionals, one located in Japan responsible for Japan based opportunities and one in Deerfield, IL or Zurich, Switzerland

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

• Experience in participating as a senior member of a company or division management team contributing to the formation and execution of strategic plans
  
• A track record in negotiating and closing a variety of research and development agreements
  
• Experience in the vaccines arena and an understanding of vaccine-related technologies
  
• Scientific (PhD, MD, or equivalent) and business (MBA or equivalent) qualification, coupled with a minimum of 10-15 years experience in the pharmaceutical or biotech/biopharmaceutical or other related industry
  
• Experience in identifying and completing transactions in both the western and in the emerging markets will be considered a plus
  
• Results oriented
  
• Independent, trustworthy, collaborative, just-do-it attitude, communicative, creative and positive mindset, team player
  
• Strong and proven people management skills and experience

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.

No Phone Calls or Recruiters Please

• Assist the Human Resources Director in determining and implementing the human resources strategy across the organization.


• Defines, models, and reinforces Takeda's culture by ensuring that HR practices are aligned with organizational objectives.


• Advises client groups on organizational and human resource issues. In partnership with the management team, proactively identifies needs and develops and implements appropriate approaches, processes and tools, and employment law and practices.


• Lead efforts to develop programs/processes to support overall effectiveness of Human Resources function.


• Guide functional leadership in the development of departmental goals, objectives, and systems that correspond with organizational strategy.


• Manage employee relations issues such as employee complaints, harassment allegations, and work/performance issues while ensuring legal compliance, leveraging employee abilities and managing risk. Effectively investigate issues, make recommendations, and take appropriate action.


• In partnership with senior leadership, develop strategy to increase organizational effectiveness as business needs change.


• Partner with senior management to identify and address leadership development needs.


• Coach the leadership teams to enhance their impact on employees to address organizational needs.


• Lead cross-functional initiatives to address business needs.


• Proactively provides HR solutions to address key business capabilities.


• Partner with Compensation department to complete equity studies, job description creation/updates/analysis process; salary planning within budgetary guidelines. Ensure strategic alignment between compensation and incentive programs and business needs.


• Serve as liaison with Talent Acquisition function to ensure workforce planning, recruiting and hiring strategies are met.


• Provide training and OD interventions to managers and employees as needed.


• Conduct exit interviews, analyze trends in turnover, hiring, promotions, separations and grievances to determine support or action needed to adjust unfavorable trends; provide reporting and analysis on turnover trends.


• Work with internal partners such as Legal, Security, Compliance, and other HR departments to resolve employee issues as appropriate.

• Bachelor's degree.


• Minimum 7 years human resources generalist experience.


• Human Resources experience in the health care or pharmaceutical industry preferred.


• Master's degree preferred.

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.

No Phone Calls Recruiters Please.

• Willingness to travel to various meetings or client sites, including overnight trips.
  
• Requires approximately 10 % travel.

• Employ cGMP QA expertise and principles during the development, manufacturing, testing, and release of investigational drug substance and drug product to ensure product quality, solve project problems, significantly influence the compliance of projects/programs, and achieve business goals.
  
• Provide strategic cGMP quality/compliance guidance to internal stakeholders by serving as GMP QA authority on pharmaceutical development teams.
  
• Serve as primary TGRD US GMP Compound Compliance Support QA liaison for Takeda/Alliance partnerships. Provide strategic quality/compliance guidance and collaborate with Takeda Group companies and functional areas to facilitate the best possible solutions for quality issues related to Alliance projects.
  
• Lead comprehensive GMP Quality Systems audits of current or new vendors in support of TGRD US’s investigational drug supply chain. Make recommendations to TGRD US management concerning the use of vendors based on audit findings.
  
• Manage GMP Compound Compliance Support QA’s strategy for the assessment of inspectional readiness at TGRD partners and external vendors (e.g. manufacturers, packagers, and laboratories) in association with TGRD regulatory submissions. Effectively interact with QA Compound Review Teams and Takeda Group Company QA units to develop and implement inspectional readiness strategies, assess potential risks, and determine necessary actions to mitigate risks.
  
• Coordinate, assist with, and/or manage GMP regulatory inspections of third-party vendors or Takeda locations.
  
• Oversee and conduct final release and disposition of investigational medicinal pproduct for use in Takeda-sponsored studies.
  
• Investigate product compliance through evaluation of batch record documentation and interactions with external vendor personnel.
  
• Manage the process to transfer compound-specific quality knowledge gained during the drug development process to the appropriate Takeda commercial product QA organization(s).
  
• Maintain awareness of emerging issues and regulatory trends, provide interpretation, and communicate effective impact assessments and mitigation plans to TGRD US management.
  
• Manage internal quality improvement; create/revise relevant SOPs.
  
• Addition duties as assigned.

• Monitors external agency and vendor service level agreements to optimize services that are performed for Takeda.
  
• Defines technical direction, standards, guidelines, and best practices for the architectural building blocks for security systems across the organization.
  
• Leads and prioritizes efforts while acting as a liaison between Takeda and external agencies to support and maintain Takeda’s critical security systems and infrastructure.
  
• Oversee daily operations of the Customer Service Office to ensure access/identification cards and security access permissions are accurate.
  
• Provides recommendations to senior security leadership team regarding short and long term global strategic security technology plan through guidance, tools and templates in coordination with appropriate internal parties. Maintains liaison with IT to ensure coordination and synergies within Takeda business segments and in support of short and long term plans.
  
• Partners with senior management to review and define site and project requirements for inclusion into the overall enterprise security program for Takeda.
  
• Assists senior security management with understanding and adopting the enterprise security systems program strategy, vision and standards.
  
• Provides recommendations on annual budgets for labor, materials, services, and other expenditures necessary for the security system mission. This includes operating budgets and capital, as well as major maintenance funding for major repairs, replacements or upgrades. Prepares and presents budget presentations to senior security leadership team for approval.
  
• Conducts security systems assessments. Helps identify, evaluate, document and report security findings/issues as necessary. Recommends risk mitigation measures that incorporate best practices and ensures standardization across the organization.
  
• Provides oversight on implementation of security systems standards to support the overall company security program strategy and policies. Interacts with all levels within the organization and acts as the subject matter expert on security and technology integration.
  
• Analyzes assessment data to identify ideas to strengthen the security posture, reduce loss and minimize risk. Composes management summaries related to the status of the enterprise security systems program projects. Provide briefings to senior management across the business segments.
  
• Leverages deep understanding of security system technology and business to proactively identify and prioritize solutions that drive business value.

• 5 Years experience in security systems/technology integration, project management and physical security within a corporate or integrator setting required.
  
• Strong functional knowledge of physical security and technological solutions to integrate security systems. Ability to identify security risks that impact assets ranging from established facilities to remote locations.
  
• Experience directing a team supporting multiple projects and multiple applications across a variety of technology platforms.
  
• Experience with planning and managing all phases of systems development such as requirements gathering, design, configuration, development, testing, conversion and application support.
  
• Functional knowledge and experience in developing, implementing, maintaining, and managing security/safety policies and procedures. Knowledge of budget processes with a minimum of (2) years experience.
  
• Must have excellent oral and written communication skills. Must be proficient in using Microsoft Office Suite programs. Must have good presentation skills and experience in presenting to all employee levels.
  
• Must initiate feedback process and seize coaching opportunities for team members, while continuously pursuing self-development and growth.

• Physical Security Professional (PSP)
  
• Certified Protection Professional (CPP)
  
• Software House Hardware and/or Software

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  
• Carrying, handling and reaching for objects.
  
• Ability to sit or stand for long periods of time while traveling.

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  
• Requires approximately 10 % travel.

• The Search and Evaluation(S&E) team is a newly established group within Takeda’s GLBD organization. The team is responsible for working closely with other relevant functions within the broader Takeda organization to (i) develop a BD strategy consistent with core therapeutic area R&D and commercial strategies outside of oncology and vaccines (ii) identify and triage opportunities consistent with the agreed strategies and (iii) lead cross-functional due diligence teams to efficiently assess and prioritize in-licensing and alliance opportunities across the R&D pipeline.
  
• As a core member of an assigned Therapeutic Area Unit (TAU), a primary responsibility of the Search and Evaluation (S&E) Director, will be to help establish the BD strategy, identify and drive significant BD opportunities aligned with that strategy, delivering upon the external innovation needs of the assigned Therapeutic Area

• Lead the global business development (GLBD) sourcing of BD opportunities in an assigned Therapeutic Area to deliver significant products of interest on a worldwide or major region (US, EU, Japan/Asia, Emerging Markets) basis that meet the strategic scientific, therapeutic and commercial needs of the assigned Therapeutic Area.
  
• Source and provide initial technical evaluation of an assigned Therapeutic Area in-licensing candidates with emphasis on later stage (<12 months from an IND and beyond) opportunities; conduct regular comprehensive screening efforts.
  
• Coordinate in-house technical evaluation and due diligence on in-licensing candidates
  
• Prepare technical components of recommendations and proposals for in-licensing candidates for senior management.
  
• Liaise effectively with GLBD’s licensing transaction teams to consummate deals
  
• Maintain thorough knowledge of:




• Assigned Therapeutic Area products in development throughout the industry.
  
• Industry trends, regulatory, legal and commercial issues
  
• Takeda's R&D and Commercial processes
  
• Assigned Therapeutic Area science as it relates to product development
  
• Takeda’s Therapeutic Area portfolio, including gaps and strengths


• Establish and maintain a broad network of relationships with potential licensors worldwide; liaise effectively with the S&E Regional Directors and leverage the Takeda organization at large (scientists, clinicians, commercial managers..) to ensure maximal sourcing capability for an assigned Therapeutic Area.
  
• Working with the VP, S&E, the rest of the S&E team and other key functions outside of GLBD, help design and implement processes for opportunity assessment and due diligence to ensure competitive superiority.
  
• Articulate Takeda's licensing goals and practices in public forums, such as, partnering meetings; be an ambassador for the Takeda GLBD brand ensuring Takeda is perceived as a “Partner of Choice”.

• Over 6 years experience in the Pharma/Biotech industry; over 4 years in R&D.
• Ph.D., M.D. or equivalent degree is required; demonstrated clinical or biological/pharmacological training and research experience in the assigned Therapeutic Area required.
• Must demonstrate the scientific knowledge and gravitas within the assigned Therapeutic Area to help drive internal BD strategy within the Therapeutic Area Unit and hold/drive meaningful discussions externally with Pharma/Biotech executives and key opinion leaders.
• A track record of success in sourcing/driving significant business development opportunities to completion in a commercial arena is required.
• Excellent understanding of processes, interfaces and interdependencies between drug development and commercialisation.
• A well established business development network within an assigned Therapeutic Area is strongly preferred along with a progressive knowledge of innovative alliance structures, industry trends and competitive issues related to pharmaceutical business development.
• Creative, results oriented self-starter with the ability to deliver.
• Strong verbal and written communication and presentation skills.
• Excellent interpersonal skills including a demonstrated ability to be effective in a matrix environment.
• Location: Deerfield, US

PHYSICAL DEMANDS:

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  
• Requires approximately 30-40% travel.

• The Search and Evaluation(S&E) team is a newly established group within Takeda’s GLBD organization. The team is responsible for working closely with other relevant functions within the broader Takeda organization to (i) develop a BD strategy consistent with core therapeutic area R&D and commercial strategies outside of oncology and vaccines (ii) identify and triage opportunities consistent with the agreed strategies and (iii) lead cross-functional due diligence teams to efficiently assess and prioritize in-licensing and alliance opportunities across the R&D pipeline.
  
• As a core member of an assigned Therapeutic Area Unit (TAU), a primary responsibility of the Search and Evaluation (S&E) Director, will be to help establish the BD strategy, identify and drive significant BD opportunities aligned with that strategy, delivering upon the external innovation needs of the assigned Therapeutic Area

• Lead the global business development (GLBD) sourcing of BD opportunities in an assigned Therapeutic Area to deliver significant products of interest on a worldwide or major region (US, EU, Japan/Asia, Emerging Markets) basis that meet the strategic scientific, therapeutic and commercial needs of the assigned Therapeutic Area.
  
• Source and provide initial technical evaluation of an assigned Therapeutic Area in-licensing candidates with emphasis on later stage (<12 months from an IND and beyond) opportunities; conduct regular comprehensive screening efforts.
  
• Coordinate in-house technical evaluation and due diligence on in-licensing candidates
  
• Prepare technical components of recommendations and proposals for in-licensing candidates for senior management.
  
• Liaise effectively with GLBD’s licensing transaction teams to consummate deals
  
• Maintain thorough knowledge of:
  
  
  
  • Assigned Therapeutic Area products in development throughout the industry.
    
  • Industry trends, regulatory, legal and commercial issues
    
  • Takeda's R&D and Commercial processes
    
  • Assigned Therapeutic Area science as it relates to product development
    
  • Takeda’s Therapeutic Area portfolio, including gaps and strengths
  
  
• Establish and maintain a broad network of relationships with potential licensors worldwide; liaise effectively with the S&E Regional Directors and leverage the Takeda organization at large (scientists, clinicians, commercial managers..) to ensure maximal sourcing capability for an assigned Therapeutic Area.
  
• Working with the VP, S&E, the rest of the S&E team and other key functions outside of GLBD, help design and implement processes for opportunity assessment and due diligence to ensure competitive superiority.
  
• Articulate Takeda's licensing goals and practices in public forums, such as, partnering meetings; be an ambassador for the Takeda GLBD brand ensuring Takeda is perceived as a “Partner of Choice”.

• 
  
  Over 6 years experience in the Pharma/Biotech industry; over 4 years in R&D.
  
  
• 
  
  Ph.D., M.D. or equivalent degree is required; demonstrated clinical or biological/pharmacological training and research experience in the assigned Therapeutic Area required.
  
  
• 
  
  Must demonstrate the scientific knowledge and gravitas within the assigned Therapeutic Area to help drive internal BD strategy within the Therapeutic Area Unit and hold/drive meaningful discussions externally with Pharma/Biotech executives and key opinion leaders.
  
  
• 
  
  A track record of success in sourcing/driving significant business development opportunities to completion in a commercial arena is required.
  
  
• 
  
  Excellent understanding of processes, interfaces and interdependencies between drug development and commercialisation.
  
  
• A well established business development network within an assigned Therapeutic Area is strongly preferred along with a progressive knowledge of innovative alliance structures, industry trends and competitive issues related to pharmaceutical business development.
  
• Creative, results oriented self-starter with the ability to deliver.
  
• Strong verbal and written communication and presentation skills.
  
• Excellent interpersonal skills including a demonstrated ability to be effective in a matrix environment.
  
• Location: Deerfield, US

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  
• Requires approximately 30-40% travel.

• Develop detailed financial models in support of a given project by working with various R&D and Commercial groups to gather inputs.
  
• Assess actual project spend and commercial results against prior forecasts to provide risk analogs for financial models.
  
• Capture relevant assumptions behind model inputs to ensure consistency across project iterations.
  
• Development of project alternative scenarios based upon varying model inputs to capture the range of project outcomes for risk assessment.
  
• Guide the discussion of the GPTs to fully inform the financial assessment of projects under consideration and to frame GPT decisions in the appropriate financial framework for the given project.
  
• Inform the GPT on the project’s impact to the overall therapeutic area portfolio.
  
• Deliver project assessments into a therapeutic area rollups for TAL consideration and further evaluation. Act as the project content expert into the TAL.

Lead, design & manage development of Excel based project evaluation models, coordinating across the TAS team and the BE team in Japan. Work to ensure model coherence and efficiency in support of project evaluations. Contribute to the active sharing of project evaluation knowledge across the US TAS and Japan BE groups to ensure a unified approach to project evaluation across Takeda.

Develop and maintain general therapeutic expertise for assigned therapeutic areas. Develop a detailed understanding of the competitive scientific and commercial landscape in terms of pipelines, payors and prescribers through discussions with GPT members and other resources within Takeda.

Assit with guidance to TALs in terms of P&L consolidation across the therapeutic area, indicification of strengths, weaknesses and oppurtunities, strategic activities to strengthen therapeutic area, and BD augmentation of the therapeutic area.

• Bachelor’s Degree in science or business
  
• Advanced degree preferred
  
• Minimum of 10 years of drug industry experience, in Clinical Research, Regulatory, Development, Commercial, Finance or IT function.
  
• A minimum of 5 years people management experience, and/or a minimum of 8 years experience leading global, cross-functional teams in a matrix environment.
  
• Broad healthcare and/or pharmaceutical business exposure highly preferred
  
• Advanced Excel skills required

• Industry knowledge – solid understanding of the pharmaceutical industry, including drug development process, global healthcare system, prescription drug distribution process (e.g. medical referrals, managed care systems, reference pricing system) etc.
  
• Therapeutic knowledge – an in-depth understanding of the disease state, treatment paradigms and future trends
  
• Product knowledge – comprehensive understanding of the medical /therapeutic usage of the products
  
• Scientific knowledge – solid understanding of disease pathophysiology, associated mechanisms of action, interpretation of basic pre-clinical and clinical data, etc.
  
• Proven leadership skills, conceptual thinking and strategic problem-solving ability
  
• Demonstrated ability to clearly communicate/present key information to senior management
  
• Proactive ability to predict issues and problem solving abilities
  
• Ability to articulate and establish processes which impact cross-functionally
  
• Ability to drive decision-making within a cross-functional and cross-cultural, global team structure
  
• Issue identification and independent resolution
  
• Strong communications skills – written and verbal
  
• Management of multiple tasks of varied complexity simultaneously
  
• Excellent organizational skills
  
• Negotiation and strong persuasive abilities
  
• Diplomacy and positive influencing abilities in a matrix management environment
  
• Presentation skills with appropriate messaging and focused recommendations
  
• Microsoft Project Professional, Excel, PowerPoint & Word

• Valid driver’s license & passport

• Proactive and timely management of market research projects which includes defining objectives, developing timelines, writing requests for proposals, selecting vendors, managing budget, generating sample lists, designing screeners and questionnaires, developing research plans, providing actionable recommendations and presenting findings.
  
• Organizes information to assist in analyzing future products and makes recommendations for the development of new products or services.
  
• Develops and maintains an understanding of specific therapeutic areas including current and future market trends.
  
• Prepares and gives presentations to senior management on matters concerning market planning and analysis, product selection, and changing business environment.
  
• Able to manage multiple projects and timelines simultaneously.
  
• Management of relationships with vendors, ad agencies, internal clients and co-promotion partner.
  
• Guides vendors on analytic plans, methodologies, and final deliverables.

• BA or BS in business, marketing, and social sciences.
  
• 2+ year's market research experience.
  
• Good working knowledge in one or more of the following: SPSS, Microsoft Office such as Excel, PowerPoint, and Word.

• Advanced degree in business, marketing, and social sciences.
  
• Experience in pharmaceutical industry.

• Complete understanding of qualitative and working knowledge of quantitative market research.
  
• Knowledge of industry practices.
  
• Knowledge of market research principles and practices.
  
• Ability to actively listen to clients to assure research design addresses business needs. Ability to actively and objectively listen to respondents to assure accurate reporting of results.
  
• Appropriate communication and presentation skills.
  
• Project planning and project management skills.
  
• Vendor and budget management.

Submit your resume and start a quality career with Takeda!

We are an equal opportunity employer.

www.takedajobs.com

No Phone Calls or Recruiters Please.

1. Collaborate with the Senior Project Manager and SPMs in delivering project strategy, goals, priorities and long-term project plans and schedules.
   
2. Act as the key meeting back-up to Senior Project Managers and SPMs in the facilitation and management of cross function teams or working groups
   
3. Capture meeting outcomes and determine next steps in terms of the cross-functional communication and coordination of action items.
   
4. Manage the logistics of a project team, plan appropriate meeting schedules and ensure communication of all meeting plans to global team members.
   
5. Utilizing drug development knowledge, provide appropriate minutes (including summary of key outcomes as well as actions items) from the various project-related meetings and work groups.
   
6. Support global activity with Japan and TGRD (US & Europe) for the development and global submission approvals for the compound.
   
7. Coordinate with the Senior Project Manager and SPMs in identifying and resolving scientific, regulatory, commercial, scheduling and budget issues related to the project.
   
8. Monitor and manage of the sub-project progress, schedules and resources to produce results defined in the CDP/Clinical Development Plan.
   
9. Update the Clinical Development Plan (CDP) on the basis of scientific, regulatory, or commercial strategy changes.
   
10. Utilize project tracking and R&D process information to identify and resolve project progress/issues.
    
11. Coordinate data collection from clinical, finance, clinical supplies and vendor management to support the Budget Workgroup.

• Work with Finance personnel as an IT liaison to perform project management, business needs analysis, solution analysis and recommendations. Facilitation of solutions that progress metrics reporting, performance management, etc.


• Propose innovative solutions and/or enhancements to existing tools to meet the needs of the Finance department and its internal customers such as reporting web portals, metrics tracking, website enhancements, etc.


• Development of new functionality for existing and new financial systems (as a "super user").


• Creation of User Requirement documents, creation of testing scenarios, ability to conduct testing sessions and ensure that solutions meet the needs of the business


• Perform maintenance and performance tuning of models, supervise production jobs (moving data in system), and perform security function and change management administration.


• Perform training administration/mentoring, gather user feedback, facilitate shared knowledge amongst users, perform front-line troubleshooting and helpdesk activities, and initiate software support requests.


• Coordinate with Financial Analysts and other functional project leads on initiatives such as Sales Force realignments and expansions to ensure that all systems and reporting tools are appropriately update.


• Develop and maintain standard policies, documents and processes to update master data and ensure consistency between various financial systems including SAP, Cognos, Expense Reporting, Payroll and interfaces such as HRIS, Fleet programs and FedEx.


• Coordinate activities between various departments within Finance, IT, outside consultants and functional area users.


• Leadership of assigned initiatives includes maintaining project timelines, accountabilities of team members, issue reporting, minutes reporting, documentation and training when appropriate.

• Bachelor's degree in Finance, Accounting or Information Technology.


• Minimum of 6 years of Finance business experience.


• A minimum of 3-4 years of SAP FICO systems experience (e.g. SAP, Data Warehouse Programs) and strong systems aptitude.


• Strong analytical skills with demonstrated business impact in previous position(s).


• Strong computer software skills (Microsoft Office Suite - Word, Excel, PowerPoint).


• Proven ability to manage large cross-functional projects Such as 2 successful system implementation experiences.

• MBA or CPA.


• PMP Certification


• Previous experience in healthcare industry.

• Communication-ability to communicate ideas and data both verbally and written, in a persuasive, organized and appropriate manner, including running meetings and preparing presentations for customer groups.


• Management-ability to set priorities and meet specific deadlines in a changing environment, ability to be flexible, accommodating, and to deal with change effectively.


• Customer Service Orientation-ability to gain trust of high-level management and leverage relationships to provide best possible financial plans and drive impactful analytical projects.


• Teamwork-ability to work effectively in and contribute to a team environment.


• Entrepreneurial-ability and desire to take ownership over activities and projects, desire to shape the organization, consistent "out of the box" thinking.

• Occasional overnight travel may be required.

• Lead global medical strategy development and supporting medical affairs activities and communications for assigned therapeutic area and prioritized Takeda compounds within therapeutic area.


• Lead the Global Medical Strategy Teams (GMSTs) for assigned compounds, by partnering with the Associate Director, GMA to support agenda development, timely follow through on GMST initiatives and deliverables, aligned GMST stakeholders representation, both regional and functional, which integrate affiliate input throughout all regions, and ensure proactive communications to all Takeda stakeholders.


• Through the GMSTs, lead the development and provide oversight for Medical Affairs strategic input into Life Cycle Management, Development, Investigator Initiated Study Research , Global Outcomes Research and other research activities for Takeda.


• Represent the Global Medical Affairs function on the Global Project/Product teams (GPT); provide therapeutic area expertise and representation of global medical affairs strategies and activities to support the needs of the compound to ensure Takeda success.


• Act as the primary point of contact for GMA with Therapeutic Area Leaders and Therapeutic Area Heads within the PDD and PRD organizations, and actively participate on relevant committees, such as GDT, PRC and other committees as assigned.


• Align medical strategies for therapeutic area with overall therapeutic area strategy through Therapeutic Area Leads and TAH’s.


• Provide therapeutic and strategic leadership to stakeholder functions including, but not limited to Global Outcomes Research, Publications, Global Professional Strategies, Global Marketing and Regional Medical Affairs teams.


• Through direct and indirect reporting lines, ensure robust global alignment and communications with Regional Medical Directors who have accountability for compounds within their assigned therapeutic areas.


• Develop and maintain relationships with global KOLs of strategic importance to Takeda through individual outreach activities, participation on Advisory Boards, Professional Associations, Congresses and other meetings of strategic importance to Takeda.


• Develop the budget for their specific therapeutic area, and oversee alignment of regional and local budgets with the global budget to avoid spend duplication and optimize Takeda’s resources globally.


• Partner with the Knowledge and Information, and the Regional Support and Compliance teams to ensure efficient and high impact knowledge transfer and on-boarding initiatives for medical affairs personnel globally.


• Oversight for promotional review process for products in their respective TA’s.


• When requested, provide input to New Business Development opportunities within the therapeutic area of expertise, and serve as the primary medical affairs contact with partner companies identified through global alliance activities.

Required:

• MD degree
  
• 7 years combined experience in either pharmaceutical industry, academic research, or healthcare management
  
• Experience with clinical research, publication activities, congress presentations, and public speaking
  
• Therapeutic are expertise

• Board certification in therapeutic area related to the position

• Ability to drive to or fly to various meetings/client sites – limited overnight. Some international travel may be required
  
• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)

• Due to travel, the work environment includes exposure to both inside and outside working conditions. Temperature and length of exposure varies depending upon meeting location and transportation.

• Industry Knowledge – understands the pharmaceutical industry regulations governing medical functions within industry activities and medical regulatory process
  
• Product Knowledge –understands medical/therapeutic impact of products; understanding of potential product applications
  
• Takeda Operations – understands Takeda’s operating structure and methods including a thorough knowledge of the foreign-owned parent company

Skills

• Leadership – ability to provide ongoing feedback and coaching to employees and guides leaders within the department in doing the same
  
• Leadership – ability to use confidence, decisiveness and a willingness to listen to influence and engage others in the accomplishment of functional goals
  
• Budget Management - ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel
  
• Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner
  
• Analytical Skills – ability to analyze a wide variety of scientific data including financial figures and market research data to make management decisions
  
• Business Process Acumen - ability to apply the knowledge of Takeda’s core business capabilities to help the organization meet its goals and desired outcomes
  
• Strategic Approach – ability to predict broad-based changes in business partner environment and translates them into functional strategies to continually meet business partner needs
  
• Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use
  
• Knowledge Management – ability to document resolution to issues and or customer concerns in a manner that ensures reusability of that resolution
  
• Pharmaceutical Industry Acumen -ability to develop and implement business solutions based on trends, opportunities, needs, and market direction within the pharmaceutical industry

• Lead global medical strategy development and supporting medical affairs activities and communications for assigned therapeutic area and prioritized Takeda compounds within therapeutic area.


• Lead the Global Medical Strategy Teams (GMSTs) for assigned compounds, by partnering with the Associate Director, GMA to support agenda development, timely follow through on GMST initiatives and deliverables, aligned GMST stakeholders representation, both regional and functional, which integrate affiliate input throughout all regions, and ensure proactive communications to all Takeda stakeholders.


• Through the GMSTs, lead the development and provide oversight for Medical Affairs strategic input into Life Cycle Management, Development, Investigator Initiated Study Research , Global Outcomes Research and other research activities for Takeda.


• Represent the Global Medical Affairs function on the Global Project/Product teams (GPT); provide therapeutic area expertise and representation of global medical affairs strategies and activities to support the needs of the compound to ensure Takeda success.


• Act as the primary point of contact for GMA with Therapeutic Area Leaders and Therapeutic Area Heads within the PDD and PRD organizations, and actively participate on relevant committees, such as GDT, PRC and other committees as assigned.


• Align medical strategies for therapeutic area with overall therapeutic area strategy through Therapeutic Area Leads and TAH’s.


• Provide therapeutic and strategic leadership to stakeholder functions including, but not limited to Global Outcomes Research, Publications, Global Professional Strategies, Global Marketing and Regional Medical Affairs teams.


• Through direct and indirect reporting lines, ensure robust global alignment and communications with Regional Medical Directors who have accountability for compounds within their assigned therapeutic areas.


• Develop and maintain relationships with global KOLs of strategic importance to Takeda through individual outreach activities, participation on Advisory Boards, Professional Associations, Congresses and other meetings of strategic importance to Takeda.


• Develop the budget for their specific therapeutic area, and oversee alignment of regional and local budgets with the global budget to avoid spend duplication and optimize Takeda’s resources globally.


• Partner with the Knowledge and Information, and the Regional Support and Compliance teams to ensure efficient and high impact knowledge transfer and on-boarding initiatives for medical affairs personnel globally.


• Oversight for promotional review process for products in their respective TA’s.


• When requested, provide input to New Business Development opportunities within the therapeutic area of expertise, and serve as the primary medical affairs contact with partner companies identified through global alliance activities.

Required:

• MD degree
  
• 7 years combined experience in either pharmaceutical industry, academic research, or healthcare management
  
• Experience with clinical research, publication activities, congress presentations, and public speaking
  
• Therapeutic are expertise

• Board certification in therapeutic area related to the position

• Ability to drive to or fly to various meetings/client sites – limited overnight. Some international travel may be required
  
• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)

• Due to travel, the work environment includes exposure to both inside and outside working conditions. Temperature and length of exposure varies depending upon meeting location and transportation.

• Industry Knowledge – understands the pharmaceutical industry regulations governing medical functions within industry activities and medical regulatory process
  
• Product Knowledge –understands medical/therapeutic impact of products; understanding of potential product applications
  
• Takeda Operations – understands Takeda’s operating structure and methods including a thorough knowledge of the foreign-owned parent company

Skills

• Leadership – ability to provide ongoing feedback and coaching to employees and guides leaders within the department in doing the same
  
• Leadership – ability to use confidence, decisiveness and a willingness to listen to influence and engage others in the accomplishment of functional goals
  
• Budget Management - ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel
  
• Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner
  
• Analytical Skills – ability to analyze a wide variety of scientific data including financial figures and market research data to make management decisions
  
• Business Process Acumen - ability to apply the knowledge of Takeda’s core business capabilities to help the organization meet its goals and desired outcomes
  
• Strategic Approach – ability to predict broad-based changes in business partner environment and translates them into functional strategies to continually meet business partner needs
  
• Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use
  
• Knowledge Management – ability to document resolution to issues and or customer concerns in a manner that ensures reusability of that resolution
  
• Pharmaceutical Industry Acumen -ability to develop and implement business solutions based on trends, opportunities, needs, and market direction within the pharmaceutical industry

• Lead global medical strategy development and supporting medical affairs activities and communications for assigned therapeutic area and prioritized Takeda compounds within therapeutic area.


• Lead the Global Medical Strategy Teams (GMSTs) for assigned compounds, by partnering with the Associate Director, GMA to support agenda development, timely follow through on GMST initiatives and deliverables, aligned GMST stakeholders representation, both regional and functional, which integrate affiliate input throughout all regions, and ensure proactive communications to all Takeda stakeholders.


• Through the GMSTs, lead the development and provide oversight for Medical Affairs strategic input into Life Cycle Management, Development, Investigator Initiated Study Research , Global Outcomes Research and other research activities for Takeda.


• Represent the Global Medical Affairs function on the Global Project/Product teams (GPT); provide therapeutic area expertise and representation of global medical affairs strategies and activities to support the needs of the compound to ensure Takeda success.


• Act as the primary point of contact for GMA with Therapeutic Area Leaders and Therapeutic Area Heads within the PDD and PRD organizations, and actively participate on relevant committees, such as GDT, PRC and other committees as assigned.


• Align medical strategies for therapeutic area with overall therapeutic area strategy through Therapeutic Area Leads and TAH’s.


• Provide therapeutic and strategic leadership to stakeholder functions including, but not limited to Global Outcomes Research, Publications, Global Professional Strategies, Global Marketing and Regional Medical Affairs teams.


• Through direct and indirect reporting lines, ensure robust global alignment and communications with Regional Medical Directors who have accountability for compounds within their assigned therapeutic areas.


• Develop and maintain relationships with global KOLs of strategic importance to Takeda through individual outreach activities, participation on Advisory Boards, Professional Associations, Congresses and other meetings of strategic importance to Takeda.


• Develop the budget for their specific therapeutic area, and oversee alignment of regional and local budgets with the global budget to avoid spend duplication and optimize Takeda’s resources globally.


• Partner with the Knowledge and Information, and the Regional Support and Compliance teams to ensure efficient and high impact knowledge transfer and on-boarding initiatives for medical affairs personnel globally.


• Oversight for promotional review process for products in their respective TA’s.


• When requested, provide input to New Business Development opportunities within the therapeutic area of expertise, and serve as the primary medical affairs contact with partner companies identified through global alliance activities.

Required:

• MD degree
  
• 7 years combined experience in either pharmaceutical industry, academic research, or healthcare management
  
• Experience with clinical research, publication activities, congress presentations, and public speaking
  
• Therapeutic are expertise

• Board certification in therapeutic area related to the position

• Ability to drive to or fly to various meetings/client sites – limited overnight. Some international travel may be required
  
• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)

• Due to travel, the work environment includes exposure to both inside and outside working conditions. Temperature and length of exposure varies depending upon meeting location and transportation.

• Industry Knowledge – understands the pharmaceutical industry regulations governing medical functions within industry activities and medical regulatory process
  
• Product Knowledge –understands medical/therapeutic impact of products; understanding of potential product applications
  
• Takeda Operations – understands Takeda’s operating structure and methods including a thorough knowledge of the foreign-owned parent company

Skills

• Leadership – ability to provide ongoing feedback and coaching to employees and guides leaders within the department in doing the same
  
• Leadership – ability to use confidence, decisiveness and a willingness to listen to influence and engage others in the accomplishment of functional goals
  
• Budget Management - ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel
  
• Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner
  
• Analytical Skills – ability to analyze a wide variety of scientific data including financial figures and market research data to make management decisions
  
• Business Process Acumen - ability to apply the knowledge of Takeda’s core business capabilities to help the organization meet its goals and desired outcomes
  
• Strategic Approach – ability to predict broad-based changes in business partner environment and translates them into functional strategies to continually meet business partner needs
  
• Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use
  
• Knowledge Management – ability to document resolution to issues and or customer concerns in a manner that ensures reusability of that resolution
  
• Pharmaceutical Industry Acumen -ability to develop and implement business solutions based on trends, opportunities, needs, and market direction within the pharmaceutical industry

• Lead global medical strategy development and supporting medical affairs activities and communications for assigned therapeutic area and prioritized Takeda compounds within therapeutic area.


• Lead the Global Medical Strategy Teams (GMSTs) for assigned compounds, by partnering with the Associate Director, GMA to support agenda development, timely follow through on GMST initiatives and deliverables, aligned GMST stakeholders representation, both regional and functional, which integrate affiliate input throughout all regions, and ensure proactive communications to all Takeda stakeholders.


• Through the GMSTs, lead the development and provide oversight for Medical Affairs strategic input into Life Cycle Management, Development, Investigator Initiated Study Research , Global Outcomes Research and other research activities for Takeda.


• Represent the Global Medical Affairs function on the Global Project/Product teams (GPT); provide therapeutic area expertise and representation of global medical affairs strategies and activities to support the needs of the compound to ensure Takeda success.


• Act as the primary point of contact for GMA with Therapeutic Area Leaders and Therapeutic Area Heads within the PDD and PRD organizations, and actively participate on relevant committees, such as GDT, PRC and other committees as assigned.


• Align medical strategies for therapeutic area with overall therapeutic area strategy through Therapeutic Area Leads and TAH’s.


• Provide therapeutic and strategic leadership to stakeholder functions including, but not limited to Global Outcomes Research, Publications, Global Professional Strategies, Global Marketing and Regional Medical Affairs teams.


• Through direct and indirect reporting lines, ensure robust global alignment and communications with Regional Medical Directors who have accountability for compounds within their assigned therapeutic areas.


• Develop and maintain relationships with global KOLs of strategic importance to Takeda through individual outreach activities, participation on Advisory Boards, Professional Associations, Congresses and other meetings of strategic importance to Takeda.


• Develop the budget for their specific therapeutic area, and oversee alignment of regional and local budgets with the global budget to avoid spend duplication and optimize Takeda’s resources globally.


• Partner with the Knowledge and Information, and the Regional Support and Compliance teams to ensure efficient and high impact knowledge transfer and on-boarding initiatives for medical affairs personnel globally.


• Oversight for promotional review process for products in their respective TA’s.


• When requested, provide input to New Business Development opportunities within the therapeutic area of expertise, and serve as the primary medical affairs contact with partner companies identified through global alliance activities.

Required:

• MD degree
  
• 7 years combined experience in either pharmaceutical industry, academic research, or healthcare management
  
• Experience with clinical research, publication activities, congress presentations, and public speaking
  
• Therapeutic are expertise

• Board certification in therapeutic area related to the position

• Ability to drive to or fly to various meetings/client sites – limited overnight. Some international travel may be required
  
• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)

• Due to travel, the work environment includes exposure to both inside and outside working conditions. Temperature and length of exposure varies depending upon meeting location and transportation.

• Industry Knowledge – understands the pharmaceutical industry regulations governing medical functions within industry activities and medical regulatory process
  
• Product Knowledge –understands medical/therapeutic impact of products; understanding of potential product applications
  
• Takeda Operations – understands Takeda’s operating structure and methods including a thorough knowledge of the foreign-owned parent company

Skills

• Leadership – ability to provide ongoing feedback and coaching to employees and guides leaders within the department in doing the same
  
• Leadership – ability to use confidence, decisiveness and a willingness to listen to influence and engage others in the accomplishment of functional goals
  
• Budget Management - ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel
  
• Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner
  
• Analytical Skills – ability to analyze a wide variety of scientific data including financial figures and market research data to make management decisions
  
• Business Process Acumen - ability to apply the knowledge of Takeda’s core business capabilities to help the organization meet its goals and desired outcomes
  
• Strategic Approach – ability to predict broad-based changes in business partner environment and translates them into functional strategies to continually meet business partner needs
  
• Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use
  
• Knowledge Management – ability to document resolution to issues and or customer concerns in a manner that ensures reusability of that resolution
  
• Pharmaceutical Industry Acumen -ability to develop and implement business solutions based on trends, opportunities, needs, and market direction within the pharmaceutical industry

• Lead global medical strategy development and supporting medical affairs activities and communications for assigned therapeutic area and prioritized Takeda compounds within therapeutic area.


• Lead the Global Medical Strategy Teams (GMSTs) for assigned compounds, by partnering with the Associate Director, GMA to support agenda development, timely follow through on GMST initiatives and deliverables, aligned GMST stakeholders representation, both regional and functional, which integrate affiliate input throughout all regions, and ensure proactive communications to all Takeda stakeholders.


• Through the GMSTs, lead the development and provide oversight for Medical Affairs strategic input into Life Cycle Management, Development, Investigator Initiated Study Research , Global Outcomes Research and other research activities for Takeda.


• Represent the Global Medical Affairs function on the Global Project/Product teams (GPT); provide therapeutic area expertise and representation of global medical affairs strategies and activities to support the needs of the compound to ensure Takeda success.


• Act as the primary point of contact for GMA with Therapeutic Area Leaders and Therapeutic Area Heads within the PDD and PRD organizations, and actively participate on relevant committees, such as GDT, PRC and other committees as assigned.


• Align medical strategies for therapeutic area with overall therapeutic area strategy through Therapeutic Area Leads and TAH’s.


• Provide therapeutic and strategic leadership to stakeholder functions including, but not limited to Global Outcomes Research, Publications, Global Professional Strategies, Global Marketing and Regional Medical Affairs teams.


• Through direct and indirect reporting lines, ensure robust global alignment and communications with Regional Medical Directors who have accountability for compounds within their assigned therapeutic areas.


• Develop and maintain relationships with global KOLs of strategic importance to Takeda through individual outreach activities, participation on Advisory Boards, Professional Associations, Congresses and other meetings of strategic importance to Takeda.


• Develop the budget for their specific therapeutic area, and oversee alignment of regional and local budgets with the global budget to avoid spend duplication and optimize Takeda’s resources globally.


• Partner with the Knowledge and Information, and the Regional Support and Compliance teams to ensure efficient and high impact knowledge transfer and on-boarding initiatives for medical affairs personnel globally.


• Oversight for promotional review process for products in their respective TA’s.


• When requested, provide input to New Business Development opportunities within the therapeutic area of expertise, and serve as the primary medical affairs contact with partner companies identified through global alliance activities.

Required:

• MD degree
  
• 7 years combined experience in either pharmaceutical industry, academic research, or healthcare management
  
• Experience with clinical research, publication activities, congress presentations, and public speaking
  
• Therapeutic are expertise

• Board certification in therapeutic area related to the position

• Ability to drive to or fly to various meetings/client sites – limited overnight. Some international travel may be required
  
• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)

• Due to travel, the work environment includes exposure to both inside and outside working conditions. Temperature and length of exposure varies depending upon meeting location and transportation.

• Industry Knowledge – understands the pharmaceutical industry regulations governing medical functions within industry activities and medical regulatory process
  
• Product Knowledge –understands medical/therapeutic impact of products; understanding of potential product applications
  
• Takeda Operations – understands Takeda’s operating structure and methods including a thorough knowledge of the foreign-owned parent company

Skills

• Leadership – ability to provide ongoing feedback and coaching to employees and guides leaders within the department in doing the same
  
• Leadership – ability to use confidence, decisiveness and a willingness to listen to influence and engage others in the accomplishment of functional goals
  
• Budget Management - ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel
  
• Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner
  
• Analytical Skills – ability to analyze a wide variety of scientific data including financial figures and market research data to make management decisions
  
• Business Process Acumen - ability to apply the knowledge of Takeda’s core business capabilities to help the organization meet its goals and desired outcomes
  
• Strategic Approach – ability to predict broad-based changes in business partner environment and translates them into functional strategies to continually meet business partner needs
  
• Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use
  
• Knowledge Management – ability to document resolution to issues and or customer concerns in a manner that ensures reusability of that resolution
  
• Pharmaceutical Industry Acumen -ability to develop and implement business solutions based on trends, opportunities, needs, and market direction within the pharmaceutical industry

The Vice President, Global Outcomes Research (GOR) is responsible for developing and implementing global strategies and supporting outcomes and other research strategies to establish the value proposition for Takeda products. This role is responsible for integration of global and regional stakeholder needs to ensure the commercial viability of the product, and will oversee the inclusion of these data needs into the product development research plans. They are responsible for leading a global, but regionally located Outcomes research team to support this work, and for overseeing the appropriate resourcing and deployment of this team. The VP will oversee all outcomes and related research data used in presentations and submission external to Takeda, such as global core value dossiers, data included in regulatory submissions or publications presented at scientific venues.

• Lead the development and inclusion of product value propositions and related outcomes strategies in Target Product Profiles (TPP), Integrated Global Development plans (IGDP), Integrated Development Strategy (IDS) and Draft Product Labels (DPL).


• Lead the cross functional teams and supporting processes to assimilate and prioritize global and regional commercial needs and to ensure strong communications between Takeda’s Global and Regional Market Access, Pricing and Reimbursement and Health Economics teams.


• Lead the interpretation of commercial product needs and design of supporting research programs, in partnership with the Global Development organization, to ensure development programs deliver the data necessary to support the commercial success of the product.


• Oversee the development, testing, & validation of Patient Reported Outcomes and QoL instruments to ensure robust and compliant data generation approaches to support product success globally.


• Lead the development of Global OR dossiers, and oversee global communication and training on dossier content


• Ensure data compliance and interpretation for all outcomes and related research data presented externally at Takeda, such as data included in regulatory submissions or publications presented at scientific venues.


• Develop and prioritize post-launch OR studies, including pan regional studies, and oversee resulting study reports and publications in the areas of comparative effectiveness, database studies, observational, direct-to-patient, employer targeted studies and others as appropriate.


• Lead a regionally deployed Outcomes research team that oversees development and execution of global, regional and local outcomes related research studies, and develop, champion and manage the Global Outcomes Resarch for the global organization.


• Participate as an active member on Takeda portfolio review decision making comittees


• Oversee the conduct of customer and key opinion leader advisory boards to support development of functions strategy and research plans as needed.