• 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.

• 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.