Head of Clinical Operations
Background & Leadership
- 15-25 years of progressive Clinical Operations experience
- Recent hands-on responsibility for trial delivery, not solely executive oversight
- Demonstrated experience building, managing, and developing Clinical Operations teams
- Recent experience within a lean biotech and/or specialty CRO environment
- Phase II-III and registrational study execution within the past 8 years
Clinical Trial Execution
- Lead clinical programs from study start-up through completion
- Drive enrollment, site management, study timelines, and milestone delivery
- Oversee operational strategy across multiple clinical development programs
Vendor & CRO Management
- Direct CRO and vendor oversight
- Manage critical path activities, risks, and escalations
- Ensure studies remain on track for quality, timelines, and budget
Strategic & Financial Leadership
- Own program budgets, forecasting, resource planning, and financial management
- Lead scenario planning and operational strategy development
- Deliver KPI-driven updates and recommendations to senior leadership
Operational Infrastructure
- Build and improve SOPs, systems, processes, and operational best practices
- Drive process optimization and organizational scalability
- Ensure compliance with GCP, regulatory requirements, and inspection readiness
Cross-Functional Leadership
- Partner closely with Clinical Development, Regulatory, Data Management, Quality, and external stakeholders
- Support protocol development, study execution, and key development milestones
- Lead teams through complex operational challenges and decision-making
Team Development
- Mentor, coach, and develop Clinical Operations staff
- Foster a high-performing, accountable, and collaborative team culture
- Provide leadership within a dynamic, resource-constrained biotech environment
FAQs
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