Dr. Leslie Ball serves as Director, Division of Scientific Investigations (DSI), Office of Compliance, Center for Drug Evaluation and Research, FDA. While in DSI she has been active in developing a risk model for selecting clinical trial sites for inspection, collaborating with the European Medicines Agency (EMA) and other international regulatory authorities, developing approaches to inspecting electronic data, and instituting process improvements for enforcement actions. Previously she served as branch chief of the DSI's Good Clinical Practice Branch II, beginning in 2003. Dr. Ball joined the FDA in 1996 as a medical officer in the Center for Biologics Evaluation and Research, Office of Vaccines Research and Review. From 2001 to 2003 she worked at the Office for Human Research Protections (OHRP), where she coordinated compliance investigations, participated in inspections of institutions and IRBs, and worked on pediatric research issues.
Dr. Ball received her MD from Georgetown University School of Medicine, where she also completed a residency in Pediatrics. She completed a fellowship in Pediatric Infectious Diseases at the Walter Reed Army Medical Center. She has served as a pediatrician at the U.S. Naval Hospital, Subic Bay, Republic of the Philippines, in private practice in suburban Maryland and at the National Naval Medical Center in Bethesda, Maryland.