Amy McKee, M.D.

Amy McKee, M.D.

Amy McKee, M.D.

Vice President, Regulatory Consulting Services

Amy has 11 years of experience the in U.S. Food and Drug Administration most recently in the role of Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate Director, OHOP, CDER. She was the signatory authority for products within Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER). She 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.

Work Experience

Amy has experience in managing, developing and implementing the multi-disciplinary reviews for marketing applications (NDAs & BLAs) within OHOP. She managed international regulatory program with outreach and program development with EMA and other regulatory bodies. Amy co-authored inter-center and intra-center draft Guidance’s to Industry on drug development with companion diagnostics and nanomaterials. She is an energetic leader with demonstrated ability to build and lead multidisciplinary teams, and to manage and influence within a matrix organization.

Prior to joining Parexel, she held several other positions at 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.

Education

Amy received her M.D. from Tulane University School of Medicine in New Orleans, LA. She was a Clinical Fellow at the National Cancer Institute/Johns Hopkins University in the Pediatric Hematology/ Oncology Fellowship Program, Johns Hopkins Hospital, Baltimore, MD and National Cancer Institute, Bethesda, MD. She is board certified with the Pediatric Hematology/Oncology and American Board of Pediatrics.

Connect With Me

We are always available for a conversation.

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