Medical Director, Clinical Development, Obesity
Regeneron Pharmaceuticals, Inc.
Medical Director, Clinical Development, Obesity
The Medical Director, Clinical Development, Obesity should be a qualified physician with pharmaceutical industry experience, preferably in the area of metabolism, in relevant areas such as obesity or Type 2 diabetes. The Director will serve as Medical Lead for clinical trials in the CDP and is responsible for the design of clinical study concepts leading to clinical trial protocols. This role requires a high-performing and highly passionate physician scientist who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research.
A typical day in the life of a Medical Director may include the following responsibilities:
- Acts as medical expert and leader in interactions with external stakeholders
- Defines clinical trial-related Clinical Development Program (CDP) goals and objectives
- Works closely with discovery teams to provide input on the next generation of targets in the field
- Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSC) based on thorough scientific review and consultation with internal and external experts
- Reviews and finalizes clinical study concepts for presentation to Therapeutic Head, Strategic Program Teams, and internal governance meetings
- Leads the Global Clinical Study Team to produce high quality program deliverables on schedule
- Responsible for the medical content of clinical study reports, the analysis of clinical data, including safety monitoring, and all activities and procedures that ensure patient safety
This job may be for you if you have the following:
- An M.D. or equivalent with board eligibility or board certification in Pediatric Endocrinology preferred; relevant experience can be acceptable.
- At least 2 years pharmaceutical industry experience (equivalent research in academia will be considered)
- Experience in metabolic disorders drug development strongly preferred
- Previous interactions with regulatory agencies or common technical document (CTD or "dossier") submission in an ICH region is an advantage
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