Associate Medical Director

OBJECTIVE: 

This position (as GPST Leader or may be GPT Leader) leads the development of the all components of the integrated development strategy and the resultant tactical clinical plan and study designs to support the global development and establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of assigned compound. The position has the overall responsibility of monitoring the progress of development of the assigned compound resulting ultimately in regulatory submissions (e.g., CTD).

 

This position has the overall responsibility for the scientific design, data interpretation and reporting of Phase I-IV clinical trials for the assigned compound. 

 

Acts as the Medical Monitor for the Clinical Studies.

 

ACCOUNTABILITIES: 

Accountable for a large-scale highly complex program that may include multiple indications.Global Cross-Functional Development Program Role i.e., GPST (US, EU), or GPT (US, EU, Japan): GPST Leader or may be 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 compound 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 clinical 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. Participate in recruiting and communicating with 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 proposes 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 compound. Establishes and maintains strong relationships with key consultants, opinion leaders and key investigators in the therapeutic area(s) relevant to the assigned compound.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.Participates in regulatory communications including written, verbal and face-to-face communications with regulatory authorities, related to the assigned compound(s).  Proposes regulatory strategy.Represents Clinical Science in cross functional teams or committees that have global program impact. Acts as the Medical Monitor for the Clinical Studies. 



EDUCATION, EXPERIENCE AND SKILLS: 

Required:MD or international equivalent plus 3 years pharmaceutical clinical research experience.

TRAVEL REQUIREMENTS:Access to transportation to attend various meetings held in proximity to the Takeda officesAble to fly to various meetings at investigator, vendor or regulatory agency sitesSome international travel will be required

Submit your resume and start a quality career with Takeda!

 

We are an equal opportunity employer.

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