Director, Clinical Operations
Core
Strategic and operational leadership for global Phase 3 clinical studies, ensuring delivery of late-stage development programs.
Role type
Director, Clinical Operations (Senior, hands-on IC with people management)
Builds
Global Phase 3 clinical studies and late-stage development capabilities
Domain
Pharmaceutical/Biotechnology, Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global Phase 3 study leadership, People management (hiring, coaching, team building), Cross-functional team leadership, CRO oversight, ICH-GCP and global regulatory compliance, Risk management and inspection readiness, Strategic planning and budget management
Preferred skills
Respiratory or immunology therapeutic area experience, Scaling clinical development functions in high-growth organizations
Technologies
Digital tools, Decentralized trial approaches
Responsibilities
Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies; Manage and develop Clinical Operations staff including hiring and performance evaluations; Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC; Oversee global study startup, site strategy, enrollment execution, and monitoring approaches; Ensure compliance with ICH-GCP and global regulatory requirements; Contribute to Clinical Operations strategy, infrastructure development, and process optimization
Seniority
Director, Senior Leadership
