Role Summary
The Medical Director, Clinical Sciences functions as clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), under leadership of Program Lead Medical Director (Program Lead MD) or Sr. Medical Director. A day in the life may include the following responsibilities: Provides clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program with minimal supervision from Program Lead MD. Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates. Supports Program Lead MD (and/or Sr. MD) and frequently lead interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal collaborators (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards. Serves occasionally as member for Global Clinical Development training programs, author or reviewer for clinical SOPs and may contribute to GCD strategy by serving on taskforces or other panels.
Responsibilities
- Provides clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program with minimal supervision from Program Lead MD.
- Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates.
- Supports Program Lead MD (and/or Sr. MD) and frequently lead interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal collaborators (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards.
- Serves occasionally as member for Global Clinical Development training programs, author or reviewer for clinical SOPs and may contribute to GCD strategy by serving on taskforces or other panels.
Qualifications
- Required: MD or equivalent, ideally with Hematology Oncology fellowship training.
- Preferred: More than 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- Medical/scientific expertise in disease area of assigned program is preferable.