As Director of the Office of Executive Programs, Mary Beth Clarke oversees a variety of Center-wide programs, including an executive project management staff, the Center’s executive secretariat function, the scientific advisory committee program, the Division of Training & Development, the office of the CDER ombudsman, CDER’s international program, and a program/administrative management team.
In addition to supervising these staff offices, Ms. Clarke serves as a senior advisor to the Center Director, assuming additional responsibility for a wide range of regulatory and public health projects. She served as coordinator for the FDA Medical Countermeasure Initiative by managing the budget process and supporting the related policy and legislative activities.
Ms. Clarke has also been leading the Generic Drug User Fee Act (GDUFA) implementation. She has spearheaded the coordination of activities for CDER and the Office of Regulatory Affairs as it pertains to GDUFA, including development of project plan encompassing human capital and infrastructure to support expanded generic drug review, inspections and compliance, and new user fee collections.
Ms. Clarke has extensive management experience and several years of experience evaluating health care and public health programs in HHS. Additionally, she has spent several years teaching undergraduate research and public health topics at Georgetown University. She received her Bachelor of Science degree in Pharmacy from the Virginia Commonwealth University in Richmond.