Senior Medical Director, Clinical Development, MASH
Regeneron Pharmaceuticals
Summary
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.
Job description
Discover your role
- 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
This role requires
- 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
- Preferred: Clinical development experience in MASH
- Preferred: Research experience in an academic setting
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
- Preferred: Clinical development experience in MASH
- Preferred: Research experience in an academic setting
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical insurance
- Dental insurance
- Vision insurance
- Life and disability insurance
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.