Paul Kluetz is a medical oncologist and Deputy Director of the Oncology Center of Excellence (OCE) at the U.S. FDA. In addition to contributing to the strategic leadership and operational oversight of the OCE, he holds a leadership role in the Office of Oncologic Drugs overseeing the regulatory review of solid tumor drug indications within the Center for Drug Evaluation and Research. Dr. Kluetz founded and leads several initiatives including creation and direction of the OCE’s patient-focused drug development program; OCE’s real-world evidence program; trial modernization efforts including pragmatic and decentralized trial designs; use of digital health technology; the OCE’s Oncology labeling program; and support of the OCE’s extramural research portfolio. He has published over 150 peer-reviewed manuscripts, and remains clinically active, caring for patients and supervising medical residents at the Georgetown University Hospital.