Executive Director, Head of Clinical Design & Delivery Center
Core
Strategic leadership of the Protocol Management Office (PMO) to ensure scientific rigor in clinical protocols, SAPs, and DMC charters, while driving innovation and efficiency in clinical development processes.
Role type
Senior IC executive director (clinical development strategy & operations)
Builds
High-quality clinical study designs, optimized development processes, and educational programs for clinical physicians and scientists
Domain
Biopharmaceuticals / Clinical Development
Required skills
Clinical protocol design and review, regulatory compliance, statistical analysis plans (SAPs), Data Monitoring Committee (DMC) charters, process optimization, AI/technology implementation, stakeholder management, strategic roadmap execution
Preferred skills
Life Sciences degree (MD, PhD, PharmD, MS, RN), experience with real-world evidence, knowledge of OneClinical model, AI/technology implementation (e.g., FARO)
Technologies
FARO, AI tools, digital innovation platforms
Responsibilities
Provide rigorous scientific review of pivotal protocols across therapeutic areas; oversee team coordination for review activities; develop and deliver educational programs for clinical physicians and scientists; lead initiatives to enhance clinical development innovation and efficiency; integrate protocol review processes into governance; implement state-of-the-art AI and technology to optimize protocols; serve as Global Process Owner for Protocol development within QMS network
Seniority
Executive, strategic leadership & mentorship