Elizabeth Walsh, PMP, ACRP-CP

Elizabeth Walsh, PMP, ACRP-CP, is a clinical development executive specializing in execution strategy and delivery across complex development programs. With more than 25 years of experience spanning sponsor organizations, CROs, and research environments, she has led global Phase I-IV programs from early development through regulatory submission and commercialization.Her work focuses on integrating clinical execution into development strategy, ensuring operational assumptions are tested early and sponsor oversight remains active across outsourced models. She has built and led Clinical Operations organizations, supported IND, NDA, and BLA submissions, and guided programs across oncology, rare disease, neurology, immunology, and infectious disease.She is the founder of Walsh Clinical Advisory, where she advises biotech sponsors on clinical execution and oversight.