Leslie O’Toole, BSN

Clinical Operations

With 37 years of experience in clinical nursing, clinical quality assurance, and clinical research operations, Leslie combines a deep understanding of patient care with extensive expertise in clinical trial management and executive leadership. Over the years, Leslie has successfully led Phase I-IV clinical trials across a wide range of complex therapeutic areas, overseeing projects from early-phase development to regulatory submission.

As a hands-on leader, Leslie has successfully built and scaled clinical operations teams, managed complex trial portfolios, and guided cross-functional teams to exceed operational goals while maintaining the highest standards of quality and compliance. Her expertise in strategic planning, risk management, and process optimization has been instrumental in driving successful outcomes in both biotech and CRO environments.   

Since 2017, Leslie has worked as a Clinical Operations and Clinical Quality Assurance consultant, taking on senior leadership roles including Senior Director of Clinical Operations, Head of Clinical Operations, Clinical Quality Program Manager, and Vice President of Clinical Operations. Leslie is passionate about fostering collaboration, developing talent, and ensuring that clinical trials are not only efficient but also ethically and scientifically sound.