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Senior Medical Director, Clinical Development, MASH

Regeneron

Senior Medical Director, Clinical Sciences, MASHAt Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. In this role, you will lead one or more MASH clinical programs from first-in-human through registration-enabling studies while collaborating with research, the Regeneron Genetics Center, regulatory affairs, clinical operations, and other partners. Evolving Genetic Medicines modalities include RNA interference (RNAi), gene editing, viral vector gene delivery, and others. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.Location: Tarrytown, NYLead one or more MASH clinical programs and serve as the clinical expert with regulators, key opinion leaders, and advisory boardsDesign and execute innovative Phase 1, 2, and 3 studies, from first-in-human through registration-enablingDevelop clinical strategies that shorten development timelines in an evolving regulatory landscapePartner with discovery scientists and translational geneticists to evaluate emerging genetic medicines targets and shape clinical experimentsProvide input to research teams on the next generation of targets in metabolic diseasesSafeguard patient safety in clinical studies and review post-marketing signals alongside Global Patient SafetyEnsure the quality of clinical documents and prepare responses to regulatory agency questions and submissionsBuild consensus across matrixed, multi-disciplinary teams and serve as a clinical role modelM.D., D.O., or equivalent medical degree and relevant specialized fellowship/residency training (MD/PhD preferred)Minimum of 3-4 years of industry clinical development experience with a track record of conducting clinical trials and/or leading clinical programsSolid knowledge of compliance and global regulatory requirements (ICH) for pharmaceutical developmentStrong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)Experience leading cross-functional or similarly diverse teamsExcellent interpersonal and stakeholder management skillsPreferred: Clinical development experience in MASHPreferred: Research experience in an academic setting

Vacancy posted more than 2 months ago

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