Sr Medical Director, Clinical Development, NASH/MASH

The Senior Medical Director, Clinical Development will play a key role in the NASH / MASH clinical development program within the Regeneron Genetic Medicines portfolio, including responsibility for driving forward one or more NASH / MASH clinical programs.

This role leads one or more clinical team working closely with key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs, clinical operations, and others.

This role leads collaborations with discovery scientists and translational geneticist colleagues to understand current and emerging targets / genetic medicines programs, provides input on potential disease areas / indications, and crafts clinical experiments that corroborate or inform the biology for decision-making purposes and enable clinical development programs.

This is an exciting opportunity to develope evolving Genetic Medicines modalities include RNA interference (RNAi), gene editing, viral vector gene delivery, and others.

A typical day in the life of a Senior Medical Director may include the following :

Leads clinical program(s) and acts as a clinical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.

g., Research, Regeneron Genetics Center, Regulatory Affairs, Global Clinical Development, Precision Medicine, HEOR), and internal decision committees.

Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.

Designs and develops efficient and innovative Phase 1, 2, and 3 programs.

• Works closely with the research and discovery teams to provide input on the next generation of targets in metabolic diseases.
• Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety.
• Ensures quality of all clinical documents (e.g., investigators’ brochure, protocol, study report, clinical components of regulatory submissions, safety related documents).
• Develops written responses to regulatory agency questions and prepares regulatory submission documents.
• Has strong consensus-building and stakeholder management skills with a strong ability to collaborate with multi-disciplinary teams towards sound decision-making.

Key member of dynamic and matrixed clinical teams in a fast-paced and hands-on environment.

This role may be for you if you have the following :

• An M.D. or D.O. or equivalent medical degree (MD / PhD preferred)and relevant residency / fellowship training is required with a strong preference for Hepatology or Gastroenterology clinical training / background.
• A minimum of 3 years of clinical development experience in an industry setting is required, with a track record of meaningful contributions to and accomplishment in conducting clinical trials (e.

g., planning, implementing, reporting and publishing) and / or leading clinical programs

• Direct clinical development experience in NASH / MASH is preferred
• Research experience in an academic setting preferred
• Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidate products is required.
• Strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out).

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