Senior Medical Director, Clinical Development, Obesity
A typical day may include the following:
- Acts as medical expert and leader in interactions with external stakeholders
- Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs and develops more efficient and innovative, yet robust Phase 2/3 programs.
- Works closely with discovery teams to provide input on the next generation of targets in the field and leads the development of plans for Phase 1 clinical testing for initial characterization of the molecules PK/PD and safety.
- 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.
- Plans and executes publication and clinical communication strategy in coordination with Publications team. Provides input to key external presentations.
- 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 regulatory submission documents.
This may be the role for you if:
- A minimum of an advanced degree in medicine (i.e., M.D. or D.O. or equivalent).
- Clinical training in Endocrinology, Cardiology, Nephrology, Internal Medicine (board certified or eligible or equivalent) is strongly preferred.
- A minimum of 3-4 years of industry experience in early or late development
- Past experience in leading clinical trials including: protocol design, managing study start-up, directing and guiding study team execution, data cleaning, medical monitoring/review, database locks.
- Experience with regulatory filings and interactions with health authorities preferred
This role requires 4 days a week / weekly on-site presence in Tarrytown, NY. Warren, NJ could also be considered.
#MDJOBSCD, #MDJOBS, #GDTherapeuticJobs
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.
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