• 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.

• 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

• 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%

• 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

• 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.

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.

ACCOUNTABILITIES:

Accountable to Therapeutic Area Head and Regional Clinical Science Head to provide strategic clinical input with emphasis on regional input.

Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed.

TA advisor supports the Development TA leader on all global objectives and ensures that the regional view is represented in the global strategy by:

• Providing regional clinical leadership and oversight within TA
  
• 
  
  Managing GDT leaders within respective region(also, may serve as GDT leader as needed)
  
  
• 
  
  Integrating and consolidating regional input from all relevant parties into the global view on TA development issues
  
  
• 
  
  Providing strategic input into global development strategies and plans for all compounds in respective TA. Regional aspects are of particular focus
  
  
• 
  
  Member of the PDD TA Leadership Team (TALT)
  
  
• 
  
  Representing PDD at TA Unit as advisory member or as delegate for the PDD TA Head as requested by the TA Head
  
  
• 
  
  Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities)
  
  
• 
  
  Primary interface with regional Medical Affairs for regional strategy and in support of product commercial efforts
  
  
• 
  
  Contributing to the creation and maintenance of regional KOL network
  
  
• 
  
  Providing recommendations for GDT leader nominations and reviewers of external compounds to TA Head
  
  
• 
  
  Liaison with Clinical Operations and Project Management for co-ordination of logistics study planing and implementation
  
  
• 
  
  May line manage other clinical science staff within TA aligned teams in region

Synopsis / Protocol Development, Study Execution, & Study Interpretation

• Consistent with membership of the TGRD Synopsis Review Committee, responsible for critical review of Synopses relating to studies in assigned compounds. .

Trial Medical Monitoring

• Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.

External Interactions

• Oversees and leads all clinical science activities involved in interactions with FDA and key opinion leaders relevant to assigned compounds.
  
• Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment.
  
• Proactive identification of challenges and development of contingency plans as appropriate.

Due Diligence, Business Development and Alliance Projects

• Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment.
  
• Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities.
  
• Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.
  
• Assigns and manages clinical science staff who are involved in many of these activities.

Leadership, Task Force Participation, Upper Management Accountability

• Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area. Leads TGRD internal teams and global cross-functional teams. Works with functional leadership to prioritize projects within the therapeutic area.
  
• Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.

• MD strongly preferred or internationally recognized equivalent with minimum 10 years pharmaceutical research experience, including minimum 7 years phases I-IV experience.
  
• Management experience in a matrix environnent.

• 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 25 % travel.

• Plans/manage/executes all regulatory activities of all levels of complexity for project of responsibility in development and/or supports regulatory activities for assigned marketed product of responsibility.
  
• Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
  
• Serves as regulatory lead on the global development team (GDT) for individual project of responsibility. Can have multiple projects depending on development stage and complexity.
  
• Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within project of responsibility.
  
• Primary FDA contact for project of responsibility.

• Working with EU co-lead (if applicable), leads the regulatory working team and represents team at GDT; ensures global regulatory strategy is written and executed according to plan.
  
• Accountable for all US FDA submissions and approvals for project(s) of responsibility.
  
• Accountable for ensuring all other regulatory submissions within the non-US "Americas" territories are submitted on schedule by local Takeda affiliates within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
  
• For the project(s) of responsibility, collaborates with EU Regulatory affairs and other regional counterparts ensuring critical deliverables to territories are provided outside the Americas to ensure regional execution of the strategy as agreed within the global regulatory strategy
  
• Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
  
• Generally serves as regulatory lead on the global development team (GDT) for individual project(s) of responsibility. Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within project(s) of responsibility.
  
• Generally the primary FDA contact for project(s) of responsibility.
  
• Executes day-to-day activities for projects.
  
• Assists and attend FDA meetings and can lead with oversight.
  
• Assists in the due diligence review of licensing opportunities.
  
• Identifies and notifies management of resource gaps for assigned project(s), when necessary.
  
• Ensure regulatory compliance of marketed products.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

• BSc Degree, preferred. BA accepted.
  
• Minimum of 5 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 5 years regulatory and/or related experience.
  
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
  
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
  
• Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
  
• Must work well with others and within teams.
  
• Able to bring working teams together for common objectives.

PHYSICAL DEMANDS:

• 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.

TRAVEL REQUIREMENTS:

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

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.

No Phone Calls or Recruiters Please.

• Serving in a leadership capacity on the GDT and RDT for complex and strategically important developmental programs including those that are Phase III and IV programs.
  
• Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to Type II variations and sNDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs.
  
• Training and mentoring of Pharmacovigilance Physicians and Specialists.
  
• Perform activities required to serve as GlobalSafety Lead:
  
  
  
  • Act as PV GDT member and lead the Global Safety Team
    
  • Review and oversight of all safety data, including non-clinical and clinical, for the product
    
  • Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities for the product globally. This includes the authorship of the DCSI and Expectedness List for a compound.
    
  • Interactions with external experts and regulatory agencies
    
  • Review of safety data and participate in dose selection in first-in-man studies and dose escalation decisions
    
  • Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
    
  • Review or generation of monthly safety reports for signal detection
    
  • Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
    
  • Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
    
  • Oversight of selection of members, set up and conduct of DSM and Advisory Board activities
    
  • Conduct aggregate analysis of emerging safety data, present to senior management within TGRD and TPC and lead strategy in response to an emerging significant safety signal
  
  
• Perform activities required to serve as regional PV physician:
  
  
  
  • Review of all local cases for the designated products
    
  • Assist with activities related to local regulatory agency interactions if required
    
  • Working knowledge and familiarity with clinical protocols, SAPs, clinical study reports and periodic reports for the product
    
  • Member of safety working group and participate in compilation and review of data to be used by the group
  
  
• Maintain professional knowledge and accreditation by active participation in continuing medical education activities.

• Medical Degree required or internationally recognized equivalent.
  
• Minimum of 4 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 2 years in global pharmacovigilance.
  
• 1 year clinical experience with patients following post-graduate training with significant knowledge of general medicine.
  
• Knowledge of principles of epidemiology and statistics.
  
• Critical thinking and analytical skills and ability to make high level decisions.
  
• Excellent oral and written communication skills including ability to present to large internal/external groups.
  
• Good level of computer literacy with Microsoft applications.

• US - Active US license preferred.
  
• EU - registered to practice in the EU.

• Routine demands of an office-based work environment.

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

• Provides leadership to the TGRD Clinical Compound Support QA function, and plays a leadership role in ensuring that investigator, vendor, facility and system audits are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented.
  
• Serves as a senior strategic GCP/PV quality resource to TGRD for its drug development activities, and takes a lead role for the preparation, conduct, and responses to regulatory agency (e.g. FDA) audits of TGRD’s Clinical Research effort.
  
• This position provides regional leadership and strategy in line with global strategic objectives. Collaborates with PDD Global Clinical Compound Support QA and with all TGRD functional areas to ensure global clinical trial activities sponsored by TGRD (US) are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda Policies and Procedures.
  
• Provides strategic direction and oversight to the Pharmacovigilance QA function.

• Provides direction to the US Clinical Compound Support Quality Assurance function to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance to applicable regulations.
  
• Dotted line reporting relationship to PDD Global Clinical Compound Support QA. Responsible for collaborating with PDD Global Clinical Compound Support QA to develop and implement a strategic audit plan for the development of all TGRD US compounds,
  
• Analyze audit program results, quality issues and investigations in order to optimize regional operations and overall regional state of compliance. Ensure that activities are conducted and reports written according to applicable SOPs and regulations.
  
• Represents TGRD and may serve as Inspection Administrator during regulatory inspections. Provides strategic organizational direction to assure that responses are timely and appropriate to maintain TGRD’s (US) good standing with regulatory agencies.
  
• Oversees all US GCP QA, PVQA, and GLP QA activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity.
  
• Works in collaboration with PDD Global Compound Compliance and PDD Quality Systems to to identify and mitigate GCP/PV/GLP quality and compliance issues with potential impact across multiple compounds, sites, or functional groups within or outside of TGRD including TGRD EU, TGRD Asia, and JDC (Japan Development Center).
  
• Collaborates with the PDD Global Compound Compliance, PDD Quality Systems, and other global Takeda entities to provide a consistent quality approach, including:
  
• 
  
  
  
  • Develops and presents periodic reports describing TGRD compliance trends and identifying areas of potential risk to TGRD senior management.
    
  • Ensures that US GCP//PV/GLP QA audit strategy is harmonized with other PDD regions..
    
  • Identify processes and procedures to incorporate Quality Control assessments at the TGRD functional group level.
    
  • Develops and maintains curriculum and standards for GCP Auditor qualification.
  
  
• Determines acceptability of vendors for potential use by TGRD US and provides direction, guidance and strategy for TGRD Quality.
  
• This position has overall responsibility for the ongoing development and operational success of the Clinical Compound Support Quality Assurance (CCSQA) function. This includes talent development and succession planning, resourcing and budgeting, and alignment of CCSQA initiatives, goals and activities with PDD, TGRD and TPC goals.

This position will oversee the work of the Clinical Safety physicians who support each therapeutic area. This position will liaise with other TGRD departments (Clinical Research, Regulatory, Pharmaco-epidemiology) to ensure comprehensive product stewardship for developmental products.

ACCOUNTABILITIES:

• 
  
  Liaise with VP, Pharmacovigilance and other Directors within Pharmacovigilance department to ensure effective functioning of the department including strategic and long-term planning and resource assessments
  
  


• 
  
  Keep leadership (within and outside Pharmacovigilance) abreast of new developments in safety for developmental compounds
  
  


• 
  
  Work closely with colleagues in TPC PV and TGRD Pharmacoepidemiology to ensure that there is global consensus on signal detection tools and activities
  
  


• 
  
  Provide training and mentorship to PV physicians with respect to medical aspects of surveillance and provide risk management training to other audiences (e.g Clinical Sciences, MSA, Legal, Regulatory, as appropriate)
  
  


• 
  
  Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues
  
  


• 
  
  Oversee risk management plans for developmental compounds
  
  


• 
  
  High Impact Global Decisions: in conjunction with Head of PV, leads and directs interpretation of safety data from internal and external studies and communicates at senior leadership level the impact of the data in terms of "go/no go" decisions or modification of development plan or study design that may have a significant impact on timeline or product labeling.
  
  

EDUCATION, EXPERIENCE AND SKILLS:

• 
  
  Medical degree required or internationally recognized equivalent.
  
  


• 
  
  Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 4 years in a global pharmacovigilance organization. Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required.
  
  


• 
  
  1 year clinical experience with patients following post-graduate training with significant knowledge of general medicine.
  
  


• 
  
  Minimum of 5 years experience in people management and well-developed skills in teambuilding, motivating and developing people.
  
  

TRAVEL REQUIREMENTS:

• 
  
  Willingness to travel to various meetings or client sites, including overnight trips. 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.

• Provides strategic and scientific leadership and provides direction for nonclinical and early clinical translational pharmacology research programs for Takeda compounds on a global basis.


• Ensures translational pharmacology plans are executed in a timely manner, meet current scientific and quality standards, and support regulatory submissions adequately.


• Ensures that technical and scientific standards meet state-of-the-art industry expectations


• Serves as a liaison with external companies, organizations, consultants, university representative, NIH, and with FDA, as required.


• Identifies, evaluates, develops and communicates/negotiates criticality of new scientific tools for effective and thorough nonclinical and early clinical translational pharmacology programs.


• Recommends animal biomarker studies and contributes to the selection of biomarker endpoints in early clinical studies.


• Provides assessment of assigned Takeda pipeline compounds and in licensing candidates within the context of translational pharmacology.


• Suggests and justifies therapeutic targets for compounds under early development and provides appropriate translational approaches for studying same.


• Develops and is responsible for scientific expertise on the translational Pharmacology and pharmacodynamics of assigned Takeda pipeline compounds and serves on Global Development Teams for assigned compounds.


• Is responsible for the preparation and/or review of nonclinical documents submitted to Regulatory Agencies within the scope of translational medicine/pharmacology.


• Works with others in Translational Medical Sciences to contribute to the dose and biomarker selection for first-in-human studies, and provides pharmacologic and pharmacodynamic rationales and translational approaches for early clinical protocols.


• Delivers presentations of nonclinical translational data to support Takeda pipeline compounds and presents these data internally and/or to external consultants.


• Collaboratively interacts with scientists in the TPC Research and Development Divisions, TSD, TSF, TCB, Takeda Singapore, with Clinical Sciences, and with scientists from alliance partnerships.


• Actively contributes to development pipeline by identifying potential targets and submitting them to the Global Target Hunting Group.


• Evaluates data and provides supporting documentation for compounds early in Takeda development being considered for Stage-up.


• Prepares and supports the translational medicine plans for compounds in development.


• Supports Business Development efforts by evaluating and providing supporting documentation for potential in licensing opportunities and for compounds under due diligence examination.

Please note that the requirements specified in this posting are the basic qualifications required for the Fellow, Translational Pharmacology position; however, job title will be dependent on the candidate's level of experience in those requirements.

• Ph.D. and minimum 9 years of pharmaceutical/academic/industry/government experience; or


• M.S. and minimum 15 years pharmaceutical/academic/industry/government experience; or


• B.S. + professional license and minimum 20 years pharmaceutical/academic/industry/government experience.


• Must be capable of utilizing the highest scientific and technical standards for the successful design and execution of translational pharmacology programs in a timely manner.


• Must use expertise to identify, evaluate, develop, and recommend novel (and scientifically sound) solutions to solve critical project issues. To do this, the incumbent must demonstrate an expert knowledge of translational pharmacology in one or more therapeutic areas.


• Should serve as a "highly credible technical expert" to outside functional areas,


• Degree is expected in relevant scientific area, e.g., Pharmacology, Psychology, Biochemistry, Molecular Biology, Cell Biology, etc.


• Recognized expertise in Pharmacodynamics and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations.


• Superior analytical, problem solving, and oral and written communication skills.


• Previous experience with translational pharmacology programs for a pharmaceutical company.


• Ability to work independently as well as to participate in a team environment.

• Ability to sit and stand for long periods of time.


• Carrying, handling and reaching for objects.