Vice President, Clinical Operations

Role Summary

The Vice President (VP) of Clinical Operations is a strategic executive responsible for providing leadership, oversight, and direction for all global clinical trial operations. The VP will drive the successful, timely, and cost-effective execution of the clinical trial portfolio, leading a high-performing Clinical Operations organization and ensuring studies are conducted in accordance with GCP, regulatory requirements, and company goals. The role also serves as deputy to the SVP, Clinical Development Operations.

Responsibilities

• Provide operational leadership for Clinical Operations across all programs, from study planning and start-up through execution and close-out.
• Oversee selection, performance and governance of CROs, external vendors, and service partners, ensuring alignment with standards, timelines, quality, and budgets.
• Partner cross-functionally with Clinical Development Operations, Regulatory Affairs, Medical, Biostatistics, Medical Affairs, and other functions to drive integrated program delivery.
• Oversee the framework for KPIs and risk management, ensuring proactive issue escalation and alignment between Clinical Operations, Clinical Outsourcing, and Quality.
• Build, mentor, and empower a high-performing Clinical Operations organization.
• Lead or contribute to regulatory submission strategies (e.g., NDA, BLA, MAA) and provide operational leadership during inspections and health authority interactions.
• Champion a culture of quality, operational excellence, and collaboration across the organization.
• Oversee implementation of best practices and standards in clinical operations, maintain SOPs, and drive continuous process improvement.
• Support strategic planning, governance meetings, and executive decision-making; act as deputy when required.

Qualifications

• Bachelor’s or advanced degree in Life Sciences or related field; ~20 years of progressive Clinical Operations experience, including at least 3 years leading a Clinical Operations department.
• Experience in rare disease, pediatric, gene therapy, or other high-complexity indications preferred.
• Proven success delivering complex global clinical programs across multiple therapeutic areas and phases.
• Experience building or scaling the clinical operations function from early-stage to late-stage in a biotech setting.
• Familiarity with global trial execution across US, EU, Japan, emerging markets and multi-region regulatory strategies.
• Experience implementing CTMS, process improvements, and change management.
• Direct experience with regulatory submissions (NDA, BLA, MAA) and marketing authorizations.
• Experience with regulatory inspections (FDA, EMA, PMDA, or other) including preparation and follow-up.
• Deep understanding of ICH GCP, FDA/EMA/global regulatory requirements.
• Strong vendor/CRO oversight, budget management, and strategic execution.
• Exceptional communication, leadership presence, and strategic decision-making skills.
• Ability to thrive in a fast-paced, dynamic, collaborative environment.

Skills

• Strategic leadership and people management
• Program management and cross-functional collaboration
• Regulatory submission and inspection readiness
• Vendor management and budget oversight
• Quality systems and process improvement
• GCP/compliance expertise

Education

• Details provided in Qualifications

Additional Requirements

• Location: Hybrid/remote; in-office presence at least 3 days per week in Bedford, MA.
• Travel: Approximately 15% travel.