Amy McKee, M.D.

Amy McKee is Chief Medical Officer and Global Head, Oncology Center of Excellence for Parexel, providing patient-focused medical and scientific leadership globally in support of the company’s Phase I to IV clinical trials. Amy joined Parexel in 2019 and most recently served as Senior Vice President and Head of Regulatory Consulting Services. In this role, she has led innovative collaborations to utilize novel endpoints in clinical trials and incorporate Real World Evidence into successful regulatory submissions as well as oncology dose optimization and master protocol and platform trial designs to accelerate clinical development.

Amy is an energetic leader with a demonstrated ability to build and lead multidisciplinary teams within a matrix organization. Before joining Parexel, Amy spent 11 years in the U.S. Food and Drug Administration, most recently as Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate Director, OHOP, CDER. She was the signatory authority for products within the Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER) and was responsible for four Divisions performing the scientific review and evaluation of hematology and oncology therapeutic drugs and biologics subject to regulation by the CDER.

Amy held several other positions in the FDA, including Deputy Office Director (acting), OHOP; Team Leader, Breast and Gynecologic; Oncology Products Team, Division of Oncology Products 1, OHOP, CDER and Medical Officer, Office of Oncology Drug Products. Amy has experience in managing, developing, and implementing multi-disciplinary reviews for marketing applications (NDAs & BLAs) within OHOP and managing international regulatory program outreach and development with EMA and other national regulatory bodies. She co-authored inter-center and intra-center draft guidances to Industry on drug development with companion diagnostics and nanomaterials.

Amy received her M.D. from Tulane University School of Medicine and her Bachelor of Arts in Russian and East European Studies from Middlebury College. She was a Clinical Fellow at the National Cancer Institute/Johns Hopkins University in the Pediatric Hematology/Oncology Program, Johns Hopkins Hospital, Baltimore, Md., and the National Cancer Institute, Bethesda, Md. Amy serves on the Board of Directors for Biocryst Pharmaceuticals (NASDQ: BCRX).