Senior Medical Director, Clinical Development, Hematology Oncology
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 Hematology team supporting Cell Therapy Clinical Development. 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.When & where:Location: Tarrytown, NY or Warren, NJTravel: 10%, to relevant congresses and conferencesDiscover your role: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 programLead 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 questionsThis role requires: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.#MDJobs #MDJobsCD #GDTherapeuticJobs #Hematology #CellTherapyDoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment witho...