Ann Meeker-O’Connell serves as the Director of the Office of Clinical Policy in the Office of the Chief Medical Officer at FDA, leading an organization designing cross-cutting policy related to clinical development and bioethics. She has over 20 years of experience in medical product development, spanning trial design, clinical operations, quality, and enterprise risk management, including prior FDA service as the Acting Director of the Division of Good Clinical Practice Compliance in CDER. Prior to FDA, Ms. Meeker-O'Connell also served in leadership positions with Vertex Pharmaceuticals and IQVIA. She received an M.S. in Pharmacology at Duke University, where she was an NIH Integrated Toxicology Fellow.