Medical Director

• Provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program, Factor XI, 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 and internal stakeholders
• 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, and 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
• Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of GCST members as appropriate
• Serves frequently as member for GCD training programs, author or reviewer for clinical SOPs
• May contribute to GCD strategy by serving on taskforces or other panels.

Senior Medical Director, Clinical Development, Factor XI

Senior Medical Director, Clinical Development, Hematology