Vice President, Clinical Operations (Reporting to Chief Clinical Operations Officer)
Major Duties and Responsibilities:
- Provide operational leadership and oversight for one or more large global clinical programs or multiple phase 1β2 studies from start-up through database lock.
- Ensure trials are executed on time, to quality standards, within budget, and aligned to corporate objectives.
- Lead Clinical Operations teams to identify risks, develop mitigation plans, and resolve operational challenges; maintain inspection readiness.
- Drive study performance using key operational metrics and continuous improvement.
- Lead, mentor, and develop Clinical Operations leaders (Senior Directors, Directors, CTMs).
- Partner cross-functionally (Clinical Science, Medical, Regulatory, Data Sciences, Clinical Compliance, Quality, Pharmacovigilance, Technical Operations) to ensure seamless execution.
- Provide executive oversight of CROs and strategic vendors; establish risk-proportionate sponsor oversight and ensure documented escalation and performance/compliance evaluation.
- Oversee study budgets, forecasts, change orders, and resource planning.
- Drive inspection readiness and ensure adherence to GCP, SOPs, regulatory requirements, and quality standards.
Core Competencies / Skills:
- Leading execution of complex global Phase 1β3 trials; manage concurrent programs.
- Systems thinking; scalable process design; use of dashboards/analytics to drive decisions.
- Process improvement experience to increase efficiency/quality/predictability.
- Influence cross-functional teams without direct authority; executive communication.
- Knowledge of ICH-GCP and global clinical trial regulations (FDA/EMA).
Qualifications:
- Bachelorβs degree in scientific, business, or health-related discipline.
- 15+ years Clinical Operations experience in biotechnology/pharma.
- Significant experience leading global Phase 1β2 and/or Phase 3 trials.
- Experience supporting regulatory authority inspections.
- 6+ years people leadership (managing senior Clinical Operations leaders).
- Ophthalmology (retina) clinical development experience strongly preferred.