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

Regeneron Pharmaceuticals • Tarrytown, GA

2d • $284,900 - $385,700 • Onsite

About The Position

The Medical Director, Clinical Sciences, MASH/Metabolism works with their supervisor and other members of the cross-functional study team to author protocols and facilitate execution of study activities and data summarization. The Medical Director leads collaborations with discovery scientists and translational colleagues to understand current and emerging genetic targets across a variety of therapeutic areas and disease states including but not limited to MASH and metabolism, rare diseases, and others; provides input on potential disease areas/indications; and crafts clinical experiments that corroborate or inform the biology for decision-making purposes and enable clinical development programs within the Regeneron Genetics Medicine Clinical Development Unit. This Medical Director will report into the VP Therapeutic Area Lead.

Requirements

• M.D. Degree (M.D./Ph.D. Degree or prior research experience preferred)
• Board Certification/Eligibility in a relevant therapeutic area (Hepatology, Gastroenterology, Endocrinology, or Nephrology preferred)
• A minimum of 2-3 years of clinical practice or industry experience is preferred
• Minimum of four days on-site weekly in Tarrytown, NY

Nice To Haves

• You want to make an impact delivering genetic medicines for patients with serious diseases
• You have specialist postgraduate clinical training and practice, and/or scientific research training and with a track record of success
• You demonstrate critical, science-to-medicine translational thinking skills and sound decision making
• You have the ability to work productively in a fast-paced collaborative working environment

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

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level