As Director of the Office of Executive Programs, Mary Beth Clarke oversees a variety of Center-wide programs, including CDER’s executive operations, legislative affairs, and project management; learning and organizational development; scientific advisory committee program; product jurisdiction and combination products; and formal dispute resolution and ombudsman services.

In addition to supervising these programs, Ms. Clarke serves as a senior advisor to the Center Director, assuming additional responsibility for a wide range of regulatory and public health projects, including new program launches, user fee negotiations, and executive recruitment.  Ms. Clarke received the Senior Executive Service Presidential Rank Award for Distinguished Service in 2018.

Prior to joining CDER, Ms. Clarke served in senior management roles evaluating health care and public health programs at HHS and as an adjunct lecturer at Georgetown University’s School of Nursing and Health Studies. She received her Bachelor of Science degree in Pharmacy from the Virginia Commonwealth University in Richmond.

Related Information

• CDER Leadership Bios