Dr. Susan McCune is the Director in the Office of Pediatric Therapeutics (OPT) in the Office of the Commissioner at the Food and Drug Administration (FDA). She joined the Agency in 2003 in the Division of Pediatric Drug Development, Office of Counter-Terrorism and Pediatric Drug Development, in the Center for Drug Development and Research (CDER). From 2005 through 2009, Dr. McCune held the positions of Associate Director and team leader in the Office of Counter-Terrorism and Emergency Coordination in CDER. She joined the Office of Translational Sciences in CDER in February, 2010 as the Deputy Director, staying in that position until January, 2017. In addition to the Deputy role, she was the lead for the Translational Medicine Team, the co-director of the Biomarker Qualification Program, and the scientific lead for the Critical Path Innovation Meetings program. In 2015, Dr. McCune worked with the Critical Path Institute to launch the International Neonatal Consortium (INC) and she has been a liaison to INC since that time.
Dr. McCune received her medical degree from George Washington University following her undergraduate degree at Harvard University. She completed her internship, residency, chief residency, and neonatal fellowship at Children’s National Medical Center in Washington, D.C. She is Board Certified in Pediatrics and Neonatal/Perinatal Medicine. For 15 years, while practicing academic pediatric and neonatal medicine at Johns Hopkins and Children’s National Medical Center, Dr. McCune continued her molecular biology research on adrenergic receptor ontogeny and expression in models of newborn brain injury in the Lab of Developmental Neurobiology, NICHD, NIH. In addition, she has a Masters in Education Technology Leadership from George Washington University, and certificates in Public Health from Georgetown and Regulatory Science from USC.