Amy McKee, MD
Amy McKee, MD, was appointed to the Board in September 2021. Dr. McKee currently serves as vice president of regulatory consulting services for Parexel, a leading global clinical research organization. Prior to joining Parexel in 2019, Dr. McKee spent more than a decade at the U.S. Food and Drug Administration (FDA) in leadership roles of increasing responsibility. She served as a primary reviewer of new drug applications (NDAs) and biologics license applications (BLAs) across multiple divisions and served as both the acting deputy director and supervisory associate director of the Office of Hematology and Oncology products where she managed four separate divisions performing NDA and BLA reviews. From January 2018 through February 2019, Dr. McKee was the deputy center director for the FDA’s Oncology Center of Excellence, which helps expedite development of innovative medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation. Dr. McKee received a B.A. in Russian and East European studies from Middlebury College and received her MD from Tulane University School of Medicine. She was a clinical fellow at the National Cancer Institute/Johns Hopkins University in the pediatric hematology/oncology fellowship program and is board certified in pediatric hematology/oncology by the American Board of Pediatrics.