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 have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $284,900.00 - $385,700.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.