Jerome Burke, M.D., Ph.D.

Dr. Jerome Burke, Jr. is a medical toxicologist (physician-scientist) with 20+ years of experience in clinical/non-clinical toxicology, translational research, regulatory affairs management for federal agencies’ product submissions, and preventative medicine. He has experience as a research trials manager and clinical informaticist, with a demonstrated history of working in pharma and research consulting.

He completed his undergraduate studies at Winston-Salem State University, graduating with a molecular biology degree and a general chemistry minor. He received his Ph.D. in Toxicology and Cancer Biology from the University of Kentucky College of Medicine. He received his M.D. from Washington University of Health and Science School of Medicine, and a Healthcare Management Graduate Certification from The Johns Hopkins University-Carey Business School. Dr. Burke also completed his post-doctoral fellowship training in pulmonary-critical care at NIH.

Currently, Dr. Burke is the Program Director for Research and Reporting at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Previously, he was a member of the team at NIH identifying the SARS coronavirus and a member of the US Army, Department of Defense, Joint Program Executive Office, Medical/Regulatory Affairs, Infectious Disease Team at the beginning of the COVID-19 virus pandemic.

*Disclaimer: The views and opinions in any capacity represent those of Dr. Jerome Burke, Jr and should not be considered to represent advice or guidance on behalf of the U.S. Food and Drug Administration.