Amgen has announced the appointment of Steven K. Galson, M.D., M.P.H., to the position of senior vice president, Global Regulatory Affairs and Safety, effective May 19. Galson will report to Sean E. Harper, M.D., executive vice president, Research and Development, and will be responsible for all regulatory and patient safety functions across Amgen.
Galson joined Amgen as vice president of Global Regulatory Affairs in October 2010. "Steven has led Amgen's regulatory team for the past three and a half years, and his success in this critical role has prepared him for these expanded responsibilities," said Harper. "Steven's deep and broad experience in both the public and private health sectors makes him an excellent choice to manage the unprecedented number of regulatory filings that Amgen has planned, and to lead our effort to continually evaluate and communicate the safety profile of our medicines."
Galson came to Amgen from Science Applications International Corporation, where he served as senior vice president for Civilian Health Operations and chief health scientist from October 2009 through October 2010.
Prior to that, Galson had a distinguished 23-year career in United States (U.S.) Public Health Service. From 2007 to 2009, he was acting U.S. Surgeon General. During the Bush-Obama transition in 2009, he was the acting Assistant Secretary for Health.
From 2001 to 2007, he served as deputy director and director of the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, where he provided leadership for the center's broad national and international programs in pharmaceutical regulation.
Prior to his arrival at the FDA, Galson was director of the Environmental Protection Agency's Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances. He has also served as the Chief Medical Officer of the U.S. Department of Energy. He began his Public Health Service career as an epidemiological investigator at the Centers for Disease Control after completing a residency in internal medicine at the hospitals of the Medical College of Pennsylvania.
Galson is the recipient of numerous awards, including the Surgeon General's Medallion and the Secretary of Energy Gold Award. He has been a member of the National Board of Medical Examiners and a peer reviewer for medical journals. He is the co-chair of the Institute of Medicine Forum on Drug Discovery, Development and Translation and a member of the Board of Directors of Vanda Pharmaceuticals.
He holds a Bachelor of Science from Stony Brook University, an M.D. from Mt. Sinai School of Medicine, an M.P.H. from the Harvard School of Public Health and an Honorary Doctor of Public Service from Drexel University. He is board certified in preventive medicine and public health and occupational medicine.