Location: Tarrytown,NY, USA
The Senior Medical Director, Clinical Development will play a key role in the NASH/MASH clinical development program within the Regeneron Genetic Medicines portfolio, including responsibility for driving forward one or more NASH/MASH clinical programs. This role leads one or more clinical team working closely with key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs, clinical operations, and others. This role leads collaborations with discovery scientists and translational geneticist colleagues to understand current and emerging targets/genetic medicines programs, 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. This is an exciting opportunity to develope evolving Genetic Medicines modalities include RNA interference (RNAi), gene editing, viral vector gene delivery, and others.
A typical day in the life of a Senior Medical Director may include the following: Leads clinical program(s) and acts as a clinical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Regeneron Genetics Center, Regulatory Affairs, Global Clinical Development, Precision Medicine, HEOR), and internal decision committees. Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs and develops efficient and innovative Phase 1, 2, and 3 programs. Works closely with the research and discovery teams to provide input on the next generation of targets in metabolic diseases. Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety. Ensures quality of all clinical documents (e.g., investigators brochure, protocol, study report, clinical components of regulatory submissions, safety related documents). Develops written responses to regulatory agency questions and prepares regulatory submission documents. Has strong consensus-building and stakeholder management skills with a strong ability to collaborate with multi-disciplinary teams towards sound decision-making. Key member of dynamic and matrixed clinical teams in a fast-paced and hands-on environment.
This role may be for you if you have the following: An M.D. or D.O. or equivalent medical degree (MD/PhD preferred)and relevant residency/fellowship training is required with a strong preference for Hepatology or Gastroenterology clinical training/background. A minimum of 3 years of clinical development experience in an industry setting is required, with a track record of meaningful contributions to and accomplishment in conducting clinical trials (e.g., planning, implementing, reporting and publishing) and/or leading clinical programs Direct clinical development experience in NASH/MASH is preferred Research experience in an academic setting preferred Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidate products is required. Strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out).
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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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)
$321,900.00 - $435,500.00