Amy McKee, M.D.


Amy McKee, M.D.

Chief Medical Officer & Global Head, Oncology Center of Excellence

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Amy McKee is Chief Medical Officer and Global Head, Oncology Center of Excellence for Parexel, providing patient-focused medical and scientific leadership globally. Amy joined Parexel in 2019 and most recently served as Senior Vice President and Head of Regulatory Consulting Services. In this role, she led innovative collaborations to utilize novel endpoints in clinical trials and incorporate real world evidence into successful regulatory submissions. Her experience also includes oncology dose optimization and master protocol and platform trial designs to accelerate clinical development.

Prior to 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, Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER). She was the signatory authority for products within OHOP and was responsible for four divisions performing the scientific review and evaluation of hematology and oncology therapeutic drugs and biologics subject to regulation by CDER. For her notable contributions to healthcare, in 2023 Amy was named a PharmaVoice 100 award recipient as well as a Healthcare Businesswomen's Association (HBA) Luminary.

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

2023 HBA Luminary

Amy McKee, Chief Medical Officer & Head of Oncology Center of Excellence was recognized by Healthcare Businesswomen's Association as a 2023 Luminary. The HBA Luminary award  recognizes women who serve as a role model in their company, actively mentor and sponsor others, help advance other women’s careers and exhibit dedication to the healthcare industry.

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