Senior Medical Director, Clinical Development, Hematology Oncology

Regeneron Pharmaceuticals•Tarrytown, GA

1d•$333,300 - $450,900•Hybrid

About The Position

The Senior Medical Director, Clinical Development provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program in Hematology Oncology with minimal supervision from Program Lead MD. Clinical deliverables may include individual protocols consistent with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, clinical communications and publications. This position offers the opportunity to give to a fast-growing, science-driven organization making a significant difference to patients worldwide.

Requirements

A M.D. degree, preferably with clinical training in a relevant disease area
More than 4 years' demonstrated experience in clinical research or drug development in an industry environment spanning clinical activities in Phases 1 through 4
Understand global regulatory environment including key regulatory agencies and approval processes
Have a strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)

Nice To Haves

People Management experience preferred but not required.

Responsibilities

Manages all operational aspects and drives execution of clinical programs in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates to ensure timely execution of assigned clinical deliverables within approved budget.
Leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards.
Ensures overall safety of the compound in collaboration with the Safety Lead for the assigned program.
Contributes to CRF’s, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program.
Leads development of clinical sections of program level regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions with minimal input from Program Lead MD.