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MM15062 - MEDICAL DIRECTOR-NEUROSCIENCE
This position (as GPST/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 of and establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of multiple compounds.
This position has the overall responsibility for the scientific design, data interpretation and reporting of Phase I-IV clinical trials for the assigned compounds. Acts as the medical monitor for the clinical studies.
Accountabilities: Accountable for a large-scale highly complex program including multiple indications or multiple programs.
Global Cross-Functional Development Program Role i.e., GPST (US, EU), or GPT (US, EU, Japan): GPST/GPT Leader. Leads team 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 COMPANY 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.
Works closely and communicates frequently with Clinical Operations and Project Management.
Competitive and Scientific information: TGRD Scientific Content Matter Expert.
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.
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 international equivalent plus 5 years pharmaceutical research experience, including at least 2 years in phases I-IV.
Travel Requirements:
Access to transportation to attend various meetings held in proximity to THE COMPANY offices
Able to fly to various meetings at investigator, vendor or regulatory agency sites
Some international travel will be required
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