Senior Medical Director, Clinical Development, Hematology Oncology
About The Position
The Senior Medical Director, Clinical Development provides clinical leadership and is responsible 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 Clinical Development Plans, clinical components of regulatory documents and registration dossiers, and brand-related medical information, clinical communications, and publications. The position offers an opportunity to contribute to a fast-growing, science-driven organization working to make a significant difference to patients worldwide. The role is based in Tarrytown, New York, or Warren, New Jersey, and involves approximately 10% travel to relevant congresses and conferences.
Requirements
- M.D. degree.
- At least 4 years of demonstrated experience in clinical research or drug development in an industry environment, spanning clinical activities in Phases 1 through 4.
- Understanding of the global regulatory environment, including key regulatory agencies and approval processes.
- Strong understanding of 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 Hematology Oncology.
- People management experience.
Responsibilities
- 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 approved budgets.
- Lead interactions with external stakeholders, including regulatory authorities, key opinion leaders, advisory boards, and patient advocacy groups, as well as internal stakeholders and decision boards.
- Ensure overall compound safety in collaboration with the Safety Lead for the assigned program.
- Contribute to CRFs, outsourcing specifications, data monitoring and validation plans, and trial analysis plans to ensure consistency across the program.
- Lead development of clinical sections of program-level regulatory documents, including Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authority questions, with minimal input from the Program Lead MD.
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
