Head of Clinical Operations

• 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


• 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

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, and processes


• 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

Desired Skills and Experience

• 15+ years clinical operations experience. Ideally in a sponsor and CRO setting (leadership positions in both are highly desired)


• 5+ years in an executive leadership role


• Proven track record growing in each role and building a team and a department


• Phase II-III and registrational execution within the past 5-10 years


• ideally immunology or opthalmology experience, but no TA required