Clinical Development Director, Obesity/Cardiovascular
Core
Lead clinical development strategy and execution for late-phase studies of maridebart cafraglutide (AMG 133) in obesity and cardiometabolic diseases.
Role type
Senior Clinical Development Director (Therapeutic Area Lead)
Builds
Global evidence generation plan, study protocols, clinical trial data, regulatory submissions, and publications for obesity/cardiovascular medicines.
Domain
Biopharmaceuticals, Obesity, Cardiovascular/Metabolic
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design and execution, medical monitoring, clinical data review and interpretation, regulatory submission authoring, KOL relationship management, scientific presentation, GCP knowledge, cross-functional collaboration
Preferred skills
Late-phase development experience in cardiometabolic areas, experience with Phase 2/3 trials in obesity/diabetes/CV, experience with electronic aggregate data review tools, experience drafting regulatory responses
Technologies
Electronic aggregate data review tools
Responsibilities
Provide clinical/scientific knowledge for global evidence generation plans; translate clinical strategy into study concepts and protocols; implement clinical trials and review data; serve as medical monitor; participate in safety and regulatory interactions; author study reports and regulatory submissions; present at advisory boards and scientific meetings
Seniority
Senior, hands-on IC with leadership potential