Senior Medical Director, Clinical Development, Classical Hematology

Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Medical Director to join our Classical Hematology team supporting our Factor XI, Thrombosis program.

In this role, you will 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. Clinical 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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a significant difference for patients worldwide.

Location:

Tarrytown, NY Travel: 10%, to relevant congresses and conferences

• 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.

• A M.D. or equivalent medical degree (e.g., D.O., MBBS), preferably with specialized clinical training in a relevant disease area such as Classical Hematology or Cardiology Significant demonstrated experience of 4+ years in clinical research 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 (start-up, conduct, close-out).
• People management experience preferred but not required.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. Salary Range (annually) $ - $

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…