Holli Hamilton has served as NCATS’ senior medical officer and medical monitor since 2014. She has extensive experience working within the National Institutes of Health (NIH) and across various federal agencies. Holli began her career in federal service at the U.S. Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research, working in the Pharmacovigilance and Epidemiology Division. She also served as a reviewer in the Division of Anti-Infective Drug Products and as a medical officer in the Office of Policy on the Pregnancy Labeling Task Force. Upon coming to NIH, Dr. Hamilton served as the first director of the Office of Clinical Research Affairs at the National Institute of Allergy and Infectious Diseases, where she supervised the clinical trials management section, the medical officers section and the Vaccine Trial and Evaluation Units. At the National Institute of Dental and Craniofacial Research, she established her role as the Institute’s senior medical officer and medical monitor, chairing a concept approval and protocol review committee to provide oversight for all clinical studies supported by the Institute.
Dr. Hamilton also has industry experience as a senior director at the MedImmune Medical Affairs department, where she was responsible for Phase IV studies and negotiated and designed the Phase IV FluMist® postmarketing study to meet FDA requirements.
Dr. Hamilton attended New York University School of Medicine, completed her internal medicine training at Duke University and completed fellowships at the University of North Carolina at Chapel Hill (UNC). She is certified in internal medicine, infectious diseases, and preventive medicine and public health. She also completed a fellowship in clinical microbiology. She holds a master of public health degree in epidemiology from the UNC School of Public Health, where she also served as a research assistant professor of medicine in the Division of Infectious Diseases.
Dr. Hamilton has practiced medicine in health departments, prisons, international settings, emergency rooms and public hospitals. She also has accreditation as a regulatory affairs professional