Vice President Clinical Operations

Overview

• Lead strategic and operational execution of global clinical trials, ensuring adherence to timelines, quality, and budget.
• Direct Clinical Trial Management and Global Site Management functions, providing oversight across all development phases.
• Contribute to portfolio strategy, evidence generation, and long-range planning as part of the leadership team.
• Translate development strategies into actionable clinical plans while building scalable operating models.
• Ensure compliance with GCP, ICH, and regional regulatory requirements across all trial sites.
• Foster a culture of accountability, quality, and continuous improvement within Clinical Operations teams.
• Collaborate with cross-functional teams to ensure integrated trial execution and operational excellence.
• Drive enrollment acceleration initiatives and proactive risk-based approaches to recruitment and retention.
• Support organizational growth through innovative solutions, including AI and automation strategies.

Key Responsibilities & Duties

• Strategically plan and execute global clinical trials, ensuring delivery within scope, timeline, and budget.
• Standardize trial management processes, tools, and metrics to support scalability and consistency.
• Develop and oversee global site strategies, including site identification, feasibility, selection, and monitoring.
• Ensure adherence to GCP, ICH, and regulatory requirements across regions and sites.
• Collaborate with Quality Assurance to support inspections, audits, and CAPA management.
• Monitor enrollment performance and implement corrective actions to optimize recruitment and retention.
• Provide clinical operations input into vendor selection, governance, and performance management.
• Lead and develop high-performing Clinical Trial Management and Site Management teams.
• Design scalable operating models and resourcing strategies to support organizational growth.

Job Requirements

• Bachelor’s degree in Life Sciences required; advanced degree (MS, MPH, PharmD, PhD) preferred.
• 15+ years of clinical operations experience within biotech, pharma, or CRO environments.
• Proven leadership experience overseeing clinical trial management and global site management functions.
• Experience leading global, multicenter trials across multiple phases, including late-stage and registration studies preferred.
• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
• Ability to assess and transform capabilities through AI and automation solutions or strategies.
• Excellent leadership, communication, and collaboration skills to foster team development and operational excellence.
• Up to 20-30% domestic and international travel required.
• Ability to work onsite four days per week (Monday through Thursday).