Senior Medical Director, Clinical Development, Classical Hematology
About The Position
Regeneron is seeking a Senior Medical Director to join its Classical Hematology team supporting the Factor XI, Thrombosis program. The position provides clinical leadership and responsibility for all clinical deliverables within an assigned section of a Hematology/Oncology clinical program, with minimal supervision from the Program Lead MD. Deliverables may include individual protocols consistent with the Clinical Development Plan (CDP), clinical components of regulatory documents and registration dossiers, brand-related medical information, and clinical communications and publications. The role manages operational aspects and drives execution of clinical programs in partnership with global line functions, the assigned Clinical Scientist, and Clinical Operations associates, ensuring timely delivery within the approved budget. It leads engagement with external stakeholders—including regulatory authorities, key opinion leaders, advisory boards, and patient advocacy groups—and internal stakeholders and decision boards. The Senior Medical Director also collaborates with the Safety Lead to ensure overall compound safety, leads development of clinical sections of program-level regulatory documents, and leads responses to Health Authority questions. The position is based in Tarrytown, New York, and involves 10% travel to relevant congresses and conferences.
Requirements
- M.D. or equivalent medical degree, such as D.O. or MBBS.
- At least 4 years of demonstrated clinical research experience within an industry environment, spanning clinical activities across Phases 1 through 4.
- Strong understanding of the global regulatory environment, including key regulatory agencies and approval processes.
- Strong understanding of the operational aspects of all phases of clinical trial conduct, including start-up, conduct, and close-out.
Nice To Haves
- Specialized clinical training in a relevant disease area, such as Classical Hematology or Cardiology.
- People management experience.
Responsibilities
- Provide clinical leadership and responsibility for all clinical deliverables within an assigned section of a Hematology/Oncology clinical program.
- Manage operational aspects and drive execution of clinical programs in partnership with global line functions, the assigned Clinical Scientist, and Clinical Operations associates, ensuring timely delivery within the approved budget.
- Lead interactions with external stakeholders, including regulatory authorities, key opinion leaders, advisory boards, and patient advocacy groups.
- Lead interactions with internal stakeholders, including Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR, and internal decision boards.
- Ensure the overall safety of the compound in collaboration with the Safety Lead for the assigned program.
- Lead development of clinical sections of program-level regulatory documents, including Investigators' Brochures, briefing books, safety updates, and IND/NDA submission documents.
- Lead responses to Health Authority questions.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability), paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
