Dr. Dionna J. Green is the Director of the Office of Pediatric Therapeutics (OPT) in the Office of the Clinical Policy and Programs in the Office of the Commissioner at the US Food and Drug Administration (FDA). OPT is a congressionally mandated office whose mission is to assure access for children to innovative, safe, and effective medical products. Dr. Green leads an organization that is responsible for spearheading, coordinating, and facilitating cross-cutting activities of the FDA in the areas of pediatric health and product development, pediatric ethics, neonatology, rare diseases, pharmacovigilance, international collaboration, regulatory science, and education and outreach. Prior to her current position, Dr. Green served as the Deputy Director of OPT. Dr. Green originally joined the FDA in 2009 and worked in the Office of Clinical Pharmacology (OCP), in the Center for Drug Evaluation and Research (CDER) as a Medical Officer with the Pediatric Clinical Pharmacology Staff where she was engaged in regulatory science research and policy work focused on identifying strategies for improving the design, efficiency, and success rates of pediatric drug development trials. She subsequently became a Medical Officer/Policy Lead with the OCP Guidance and Policy Team, which was charged with the systematic identification, development, and implementation of contemporary clinical pharmacology-related FDA guidances, policies and procedures. Dr. Green has given numerous invited national and international presentations and published several peer-reviewed articles and book chapters on topics such as pediatric clinical pharmacology, pediatric clinical trial design, and pediatric product development and regulatory considerations. Dr. Green received her medical degree from the Howard University College of Medicine in Washington, D.C., and her clinical training in pediatric medicine from the Herman & Walter Samuelson Children’s Hospital at Sinai in Baltimore. She completed a clinical pharmacology research fellowship with the Georgetown University Drug Discovery Program, and a regulatory science fellowship with the FDA Commissioner’s Fellowship Program. Dr. Green is the President of the American College of Clinical Pharmacology (ACCP), as well as a Fellow of ACCP. She also serves as the ACCP Senior Representative to the Association of American Medical Colleges (AAMC) Council of Faculty and Academic Societies (CFAS).