About

I am a senior clinical operations leader with more than 18 years of experience guiding clinical programs from pre-IND through global, pivotal Phase 3. I work with biotech and pharmaceutical companies to build effective operational strategies, accelerate timelines, and lead cross-functional teams through complex development milestones.

My background includes operational strategy, study rescue, vendor governance, global study start-up, site engagement, and inspection readiness. I’ve held leadership roles at Sage Therapeutics, Clexio Biosciences, Synlogic Therapeutics, Summit Therapeutics, and Massachusetts General Hospital, building on earlier hands-on experience as a study coordinator. After working with investigators at Massachusetts General Hospital supporting development of fecal microbiota transplantation approaches, I joined Seres Therapeutics. There, I supported the Phase 2 trial and served as the lead Clinical Trial Manager for the Phase 3 program for SER-109, later approved and marketed as VOWST®, a first-in-class orally administered microbiome therapeutic. In subsequent roles, I have led clinical operations across multiple programs and therapeutic areas, building and mentoring teams while overseeing the end-to-end execution of complex clinical development programs spanning live biotherapeutic products, biologics, and small molecules.

Through Courtney Clinical Consulting, I work with biotech and pharmaceutical companies to deliver high-impact clinical operations leadership and hands-on execution, adapting the scope and structure to meet each organization’s needs. I support programs across a wide range of therapeutic areas and development stages.