Dr. Jacqueline A. O’Shaughnessy is Deputy Director of the Office of the Chief Scientist. In this capacity, she supports the FDA Chief Scientist in leading and coordinating the FDA’s cross-cutting scientific and public health efforts.
The Office of the Chief Scientist (OCS) works closely with the FDA’s product centers and offices, providing strategic leadership and support for the agency’s regulatory science research and innovation initiatives, including the National Center for Toxicological Research, The Office of Regulatory Science and Innovation, FDA’s Technology Transfer Program, The Office of Scientific Professional Development, The Office of Scientific Integrity, The Office of Laboratory Safety, the Advisory Committee Oversight and Management Staff and the Medical Countermeasures Initiative.
Dr. O’Shaughnessy began her career at the FDA in 1996 as a pharmacologist in the Center for Drug Evaluation and Research’s (CDER) former Division of Scientific Investigations, Office of Compliance. As a member of the division’s Good Laboratory Practice (GLP) and Bioequivalence (BE) Investigations Branch, she provided scientific and technical expertise on regulatory policy and complex data analysis, directed numerous multifaceted GLP and BE inspections within and outside the U.S., and served as Acting GLP Team Lead from 2009-2011. Dr. O’Shaughnessy joined CDER’s Office of Medical Policy (OMP) in 2011 as a Health Scientist Policy Analyst, where she led the development of and had primary drafting responsibility for rulemaking and guidance related to medical policy issues, including human subject protection and good clinical practice. She subsequently transitioned to the role of Deputy Director and then Director of the Division of Medical Policy Development in OMP’s Office of Medical Policy Initiatives (OMPI), and finally to Deputy Director of OMPI. In OMPI, she provided oversight and direction for the development of medical and scientific policy pertaining to drug development and regulatory review processes, in collaboration with various program areas and coordinating committees. Dr. O’Shaughnessy joined OCS as a Senior Advisor in 2017, providing scientific and technical guidance and advice in developing and implementing OCS regulatory science guidelines and initiatives. She transitioned to the role of Deputy Director of OCS in 2021 and also served as Acting Chief Scientist from October 2021 until July 2022.
Dr. O’Shaughnessy received her Ph.D. in Pharmacology and Toxicology from the University of Medicine and Dentistry of New Jersey Graduate School of Biomedical Sciences. She completed post-doctoral training at the Rutgers University Environmental and Occupational Health Sciences Institute.