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

Role Summary

The Medical Director, Clinical Sciences, MASH/Metabolism leads cross-functional teams to author protocols, facilitate study activities, and summarize data. Works with discovery scientists and translational colleagues to understand current and emerging genetic targets across multiple therapeutic areas, providing input on potential disease areas and crafting clinical experiments to inform biology and enable clinical development programs.

Responsibilities

• Leads the cross-functional study team to craft novel clinical development strategy for genetic medicines, including First in Human (FIH), Phase 2, and Phase 3 clinical trials
• Responsible for the relevance and accuracy of medical science underpinning of clinical study based on detailed scientific review and consultation
• Authors, reviews, and finalizes the medical and scientific portions of study strategies and clinical study protocols and amendments
• Authors, reviews, and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions
• Accountable for timely clinical trial execution, reviewing adverse events, monitoring patient health, and quality of results
• Analyzes the benefits and risk aspects of an assigned therapeutic candidate
• Ensures clinical team compliance with FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety
• Authors clinical sections of communications/documentation for regulatory agencies and may participate in meetings as needed
• Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives

Qualifications

• Required: MD Degree (MD/PhD degree or prior research experience preferred); Board Certification/Eligibility in a relevant therapeutic area (Hepatology, Gastroenterology, Endocrinology, or Nephrology preferred); minimum of 2–3 years of clinical practice or industry experience preferred; minimum of four days on-site weekly in Tarrytown, NY
• Preferred: Specialist postgraduate clinical training and practice, and/or scientific research training with a track record of success
• Preferred: MD/PhD degree or equivalent research experience

Education

• M.D. (MD) Degree; MD/PhD or equivalent research experience preferred