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

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.

As a Medical Director, a typical day might include the following:

• 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

This role may be for you if:

• 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

To be considered for this role, you must have an 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. This role requires a minimum of four days on-site weekly in Tarrytown, NY.

#MDJOBS, #MDJOBSCD

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 . 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)

$284,900.00 - $385,700.00