Medical Director, Clinical Development, MASH/Metabolism (Regeneron Genetics Medicine)
Regeneron
June 27, 2026
On-site
Tarrytown, NY
Clinical Research and Development
Medical Director, Clinical Sciences (MASH/Metabolism)
Role responsibilities:
- Work with the cross-functional study team to author protocols, facilitate study execution, and support data summarization.
- Lead collaborations to understand current and emerging genetic targets across therapeutic areas and disease states, including MASH/metabolism and rare diseases.
- Provide input on potential disease areas/indications and craft clinical experiments that corroborate or inform biology for decision-making.
- Lead the cross-functional team to develop clinical development strategy for genetic medicines (FIH, Phase 2, Phase 3).
- Ensure medical/scientific relevance and accuracy through detailed scientific review and consultation.
- Author, review, and finalize medical/scientific portions of study strategies, clinical protocols, and amendments.
- Author/review trial documents (monitoring plans, SAPs, amendments, IRB/IEC and regulatory submissions).
- Accountable for timely clinical trial execution; review adverse events and monitor patient health and result quality.
- Analyze benefits and risk of assigned therapeutic candidates.
- Ensure compliance with FDA, EMEA, ICH, GCP guidelines and SOPs regarding safety.
- Author clinical sections of communications/documentation for regulatory agencies; participate in meetings as needed.
- Conduct literature reviews and analyze development opportunities.
Qualifications:
- M.D. degree (M.D./Ph.D. or prior research experience preferred).
- Board Certification/eligibility in a relevant therapeutic area (Hepatology, Gastroenterology, Endocrinology, or Nephrology preferred).
- 2–3+ years of clinical practice or industry experience preferred.
- Requires a minimum of four days on-site weekly in Tarrytown, NY.
Preferred skills:
- Science-to-medicine translational thinking and sound decision-making.
- Ability to work productively in a fast-paced, collaborative environment.
Application instructions:
- “Apply now” to be considered for this role.
Role responsibilities:
- Work with the cross-functional study team to author protocols, facilitate study execution, and support data summarization.
- Lead collaborations to understand current and emerging genetic targets across therapeutic areas and disease states, including MASH/metabolism and rare diseases.
- Provide input on potential disease areas/indications and craft clinical experiments that corroborate or inform biology for decision-making.
- Lead the cross-functional team to develop clinical development strategy for genetic medicines (FIH, Phase 2, Phase 3).
- Ensure medical/scientific relevance and accuracy through detailed scientific review and consultation.
- Author, review, and finalize medical/scientific portions of study strategies, clinical protocols, and amendments.
- Author/review trial documents (monitoring plans, SAPs, amendments, IRB/IEC and regulatory submissions).
- Accountable for timely clinical trial execution; review adverse events and monitor patient health and result quality.
- Analyze benefits and risk of assigned therapeutic candidates.
- Ensure compliance with FDA, EMEA, ICH, GCP guidelines and SOPs regarding safety.
- Author clinical sections of communications/documentation for regulatory agencies; participate in meetings as needed.
- Conduct literature reviews and analyze development opportunities.
Qualifications:
- M.D. degree (M.D./Ph.D. or prior research experience preferred).
- Board Certification/eligibility in a relevant therapeutic area (Hepatology, Gastroenterology, Endocrinology, or Nephrology preferred).
- 2–3+ years of clinical practice or industry experience preferred.
- Requires a minimum of four days on-site weekly in Tarrytown, NY.
Preferred skills:
- Science-to-medicine translational thinking and sound decision-making.
- Ability to work productively in a fast-paced, collaborative environment.
Application instructions:
- “Apply now” to be considered for this role.