Medical Director, Clinical Sciences, MASH/Metabolism (Regeneron Genetics Medicine)

As a Medical Director, Clinical Sciences (MASH/Metabolism), you will work with a cross-functional study team to author protocols and facilitate study execution and data summarization. Lead collaborations with discovery scientists and translational colleagues to understand current and emerging genetic targets (including MASH/metabolism, rare diseases, and others), provide input on potential disease areas/indications, and craft clinical experiments to corroborate/inform biology and support clinical development programs.

Typical responsibilities:
- Lead the cross-functional study team to craft clinical development strategy for genetic medicines (FIH, Phase 2, Phase 3)
- Ensure medical science relevance and accuracy via scientific review and consultation
- Author, review, and finalize medical/scientific portions of study strategies, clinical protocols, and amendments
- Author/review/edit trial documents (monitoring plans, SAPs, amendments, IRB/IEC submissions, regulatory submissions)
- Accountable for timely trial execution; review adverse events; monitor patient health; ensure quality of results
- Analyze benefits and risk of assigned therapeutic candidate
- Ensure compliance with FDA/EMEA/ICH/GCP and safety SOPs
- Author clinical sections for communications/documentation for regulatory agencies; participate in meetings as needed
- Conduct literature reviews and analyze development opportunities from mechanistic, pharmacological, and clinical development perspectives

Qualifications (required/preferred):
- MD degree (MD/PhD or prior research experience preferred)
- Board certification/eligibility in relevant therapeutic area (Hepatology, Gastroenterology, Endocrinology, or Nephrology preferred)
- 2–3+ years of clinical practice or industry experience preferred
- On-site presence: minimum of four days per week in Tarrytown, NY