Director, Clinical Operations

Director, Clinical Operations

Work Location: San Mateo County, California

Summary:

Lead and develop a high-performing clinical operations function, establishing scalable systems and processes to support multi-site clinical trials. Oversee operational strategy, site management, risk mitigation, and team development to ensure consistent, high-quality execution of clinical programs.

Responsibilities:

• Develop and implement scalable clinical operations models, processes, and tools to support multi-study, multi-site clinical trial execution.
• Establish and monitor key performance indicators and dashboards to track study health, including enrollment, data quality, and site performance.
• Oversee site management and monitoring strategies, ensuring effective resource allocation and high-quality site engagement.
• Lead and mentor the clinical operations team, fostering professional growth and ensuring clear roles and responsibilities.
• Identify operational risks proactively and implement mitigation strategies, including root cause analysis and corrective actions.
• Manage clinical trial budgets, resource allocation, and forecasting to ensure efficient and cost-effective study execution.
• Collaborate cross-functionally with internal and external partners to ensure aligned and effective study execution.
• Ensure adherence to regulatory guidelines, internal procedures, and quality standards, maintaining inspection readiness across all studies.

Qualifications:

• Bachelor’s degree in a scientific, clinical, or health-related field required; advanced degree preferred.
• Minimum 10 years of progressive clinical operations experience, including significant leadership of clinical studies and teams in regulated environments.
• Experience building or scaling clinical operations infrastructure, including processes, monitoring strategies, and site management models.
• Proven ability to establish operational KPIs, dashboards, and performance management systems for clinical trials.
• Demonstrated experience leading multi-site clinical studies from start-up through closeout, including regulatory submission studies.
• Experience in diagnostic clinical trials required; infectious disease diagnostics experience preferred.
• Strong people leadership skills, including building, managing, and developing high-performing teams across multiple roles and levels.
• Ability to create structure and drive accountability in environments with junior or developing teams.

Published Category: Clinical Operations & Development