Director Program Operations Leader
Core
Lead operational strategy and delivery for complex clinical programs, overseeing quality, timelines, budgets, and study team success.
Role type
Director, Clinical Trial Management Program Operations
Builds
Clinical development programs for life-changing medicines
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical program leadership, operational strategy, budget management, CRO/vendor oversight, regulatory compliance (ICH/GCP), risk mitigation, cross-functional collaboration, team management
Preferred skills
Advanced degree, innovative problem-solving approach
Technologies
None stated
Responsibilities
Lead operational strategy and overall delivery for complex clinical programs; Oversee program quality, timelines, budgets, and study team success; Provide operational input to Clinical Study Concepts, feasibility, timelines, and cost estimates; Review plans during protocol design, study startup, and study conduct; Drive decisions, monitor KPIs, and implement risk mitigation strategies; Lead vendor selection, CRO oversight, governance activities, and partner meetings; Ensure inspection readiness and lead cross-functional support for Regulatory Authority inspections
Seniority
Director, strategic leadership with hands-on oversight
