Senior Medical Director, Clinical Development, Cell Therapy

Build our future together at Regeneron, where we use science and innovation to develop life-changing medicines for people with serious diseases. Join our Hematology team as a Senior Medical Director supporting Cell Therapy Clinical Development.

About the role

Provide clinical leadership and responsibility for all clinical deliverables within an assigned section of a clinical program in Hematology/Oncology, operating 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.

Location: Tarrytown, NY or Warren, NJ. Travel: 10% to relevant congresses and conferences.

Responsibilities

• Manage all operational aspects and drive execution of clinical programs, in partnership with global line functions, the assigned Clinical Scientist, and Clinical Operations associates, to ensure timely execution of assigned clinical deliverables within approved budget.
• Lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) and internal stakeholders (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, Health Economics & Outcomes Research [HE&OR]), as well as 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, such as Investigators' Brochures, briefing books, safety updates, and IND/NDA (Investigational New Drug/New Drug Application) submission documents, and lead responses to Health Authority questions.

Requirements

• A M.D. or equivalent medical degree (e.g., D.O., MBBS), preferably with clinical training in a relevant disease area such as Hematology or Oncology.
• Significant demonstrated experience of 4+ years in clinical research within an industry environment, spanning clinical activities across Phases 1 through 4. Cell Therapy experience preferred.
• 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 (start-up, conduct, close-out).
• People management experience preferred but not required.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• Annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match.
• Health and wellness programs, fitness centers, insurance benefits (e.g., medical, dental, vision, life, and disability).
• Paid time off and family support benefits.

For additional information about Regeneron benefits in the U.S., visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, details will be provided during the recruitment process.

Pay

Salary Range (annually): $333,300.00 - $450,900.00.