Medical Director

• Provides clinical leadership and is 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.
• Ensures timely execution of assigned clinical deliverables within approved budget.
• Supports Program Lead MD and frequently lead 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.
• Supports Program Lead MD in ensuring 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.
• Contributes/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.
• Ensures career development of GCD colleagues through active participation in the performance management and talent planning processes.

Senior Medical Director, Clinical Development, Hematology

Senior Medical Director, Clinical Development, Factor XI