Senior Director, Clinical Operations
Core
Provide strategic and operational leadership for planning and execution of early-stage clinical development programs (clinical pharmacology and Phase I/II) across a biotech portfolio.
Role type
Senior Director, Clinical Operations
Builds
Early-stage clinical trials for biotechnology companies
Domain
Biotechnology / Clinical Development
Required skills
Clinical operations strategy, CRO and vendor lifecycle management, global operational planning, risk mitigation, budget management, regulatory compliance (ICH-GCP, FDA, EMA), team mentorship, change management
Preferred skills
Advanced degree in scientific discipline, experience with decentralized trials and AI-enabled analytics
Technologies
Digital technologies for trial execution, AI-enabled operational analytics
Responsibilities
Lead clinical operations for multiple early development programs; Develop operational strategy aligned with program priorities; Lead studies from protocol development through closeout; Oversee CRO and vendor performance; Ensure compliance with global regulations; Develop and mentor clinical operations staff
Seniority
Senior Director, strategic leadership with hands-on execution