We are seeking a qualified physician scientist with significant pharmaceutical/biotechnology sector and/or exceptional academic clinical trials' experience. With oversight from supervisor, works with other members of the cross-functional team to interface with research functions and evaluate emerging targets, conceptualize and document clinical development program strategies, author clinical development protocols and facilitate/lead execution of study activities and data summarization. As appropriate will also participate in business development activities and in collaborations with key partners outside of Regeneron. The Neuroscience Therapeutic Area encompasses programs for Central Nervous System, Peripheral Nervous System, Neuromuscular and Muscular Diseases.
As a Senior Medical Director, a typical day may include the following:
- Leads the clinical science function at the Strategic Program Team, represents clinical and experimental science functions at that Team, including Precision Medicine, Imaging and Digital Medicine functions.
- Contributes to overall Program strategy and interacts with Regulatory, Clinical Pharmacology, Research, Non Clinical functions, and more, to create and deliver integrated clinical development plans, working alongside the Global Strategy Head for the Program.
- Designs POC-enabling human studies, First-In-Human (FIH) studies, POC (clinical and/or pharmacologic) studies as per clinical strategy; Reviews, edits and finalizes clinical trial plans.
- Responsible for the relevance and accuracy of medical science underpinning the clinical study, based on thorough scientific review and consultation with internal and external experts.
- Organizes and conducts consultations with global clinical and scientific experts.
- Authors, reviews and finalizes the medical and scientific portions of protocol synopsis and clinical study protocols and amendments; Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions.
- Analyzes the benefits and risk aspects of an assigned therapeutic candidate: Responsible for the analysis of clinical data, including safety monitoring, responsible for activities and procedures that ensure patient safety, ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
- With oversight from the GM&ES CDU TFA Primary Responsible, takes lead on major/significant collaborations with Research and Regeneron Genetic Center (RGC) colleagues to understand current and emerging targets/molecule program, provide clinical input on potential disease areas/indications, and design clinical experiments that corroborate or inform the biology for decision-making purposes.
This role may be for you if:
- Works productively in a fast-paced collaborative environment.
- Demonstrated critical thinking skills and sound decision-making.
- Prior experience with mentoring and leading cross functional teams.
- Contributes to Genetic Medicines Therapeutic Area activity by interacting with peers, presenting project work and attending the presentations of others, actively participating in cross-project learning and best practice improvements.
To be considered for this role, you must have an M.D. degree. Board Certification/Eligibility in a relevant therapeutic area (including but not limited to Neurology, Psychiatry, Pediatrics) along with relevant industry experience. Additionally, Ph.D. degree or extensive laboratory research experience. We are seeking 4 – 8 years of clinical research pharmaceutical industry experience, or significant relevant experience in academic clinical trials (10 years post fellowship clinical and research experience, associate or full professorship preferred). We need an individual who has authored and published in medical/scientific peer-reviewed journals. Interactions with Regulatory agencies or Common Technical Document (CTD or “dossier”) submission in any ICH region are an advantage. Effective communications (verbal & written) and presentation skills are essential.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Salary Range (annually): $321,900.00 - $435,500.00
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