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