Senior Medical Director, Clinical Development, MASH

Regeneron Pharmaceuticals•Tarrytown, GA

29d•$333,300 - $450,900•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Medical Director, Clinical Sciences, MASH to join our Genetic Medicines clinical development team. 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.

Requirements

M.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 programs
Solid knowledge of compliance and global regulatory requirements (ICH) for pharmaceutical development
Strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)
Experience leading cross-functional or similarly diverse teams
Excellent interpersonal and stakeholder management skills

Nice To Haves

Clinical development experience in MASH
Research experience in an academic setting

Responsibilities

Lead one or more MASH clinical programs and serve as the clinical expert with regulators, key opinion leaders, and advisory boards
Design and execute innovative Phase 1, 2, and 3 studies, from first-in-human through registration-enabling
Develop clinical strategies that shorten development timelines in an evolving regulatory landscape
Partner with discovery scientists and translational geneticists to evaluate emerging genetic medicines targets and shape clinical experiments
Provide input to research teams on the next generation of targets in metabolic diseases
Safeguard patient safety in clinical studies and review post-marketing signals alongside Global Patient Safety
Ensure the quality of clinical documents and prepare responses to regulatory agency questions and submissions
Build consensus across matrixed, multi-disciplinary teams and serve as a clinical role model