Senior Medical Director, Clinical Development, MASH

Regeneron Pharmaceuticals, Inc.; Tarrytown (GA); On-site; USD 333,000 - 451,000; Full time

Job summary

Regeneron Pharmaceuticals in Tarrytown, NY seeks a Senior Medical Director, Clinical Sciences, MASH to lead one or more clinical programs from first‑in‑human through registration‑enabling studies. You will partner with genetics centers, regulatory affairs, and operations to design innovative trials and shape clinical strategies.

The role requires an MD/DO or equivalent with 3–4 years of industry experience, strong regulatory knowledge, and a track record leading diverse teams.

Qualifications

• MD/DO or equivalent medical degree with relevant fellowship/training.
• 3–4+ years in industry clinical development with trials leadership.
• Solid knowledge of ICH/global regulatory requirements for pharma development.
• Strong understanding of operations across all phases of clinical trials.
• Experience leading cross-functional teams and managing stakeholders.
• Preferred: Clinical development experience in MASH
• Preferred: Research experience in an academic setting

Responsibilities

• Lead one or more MASH clinical programs and serve as clinical expert to regulators and advisory boards.
• Design and execute Phase 1–3 studies from first-in-human to registration.
• Develop strategies to shorten development timelines in evolving regulatory landscapes.
• Partner with discovery scientists to evaluate targets and shape clinical experiments.
• Provide input to research teams on next generation targets in metabolic diseases.
• Safeguard patient safety and review post-marketing signals with Global Patient Safety.
• Ensure quality of clinical documents and respond to regulatory inquiries.
• Build consensus across matrixed, multi-disciplinary teams.

Skills

Interpersonal skills

Stakeholder management

Cross-functional leadership

Regulatory understanding

Education

MD/DO or MD/PhD

Job description

Build our future together:

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.

When & where:

• Location: Tarrytown, NY

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 teamsli>Excellent interpersonal and stakeholder management skills
• Preferred: Clinical development experience in MASH
• Preferred: Research experience in an academic setting

#MDJOBSCD, #MDJOBS

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$333,300.00 - $450,900.00