Darcy DiFede is a recognized leader in clinical research operations and regulatory compliance with deep experience across academic medical centers, biotech, and international healthcare development. She founded a biological consulting firm that catalyzed collaborations with world-class clinicians and institutional partners, including initiatives to design and build hospitals abroad such as in Morocco.

Her leadership in oncology was demonstrated as Administrative Director of Clinical Research Operations at Miami Cancer Institute, Baptist Health South Florida, where she restructured the oncology clinical trials department and oversaw operations for Phase I–IV therapeutic studies, including management of the chemotherapy treatment unit. Previously, Darcy served as Director of Clinical Research at the University of Miami Miller School of Medicine’s Interdisciplinary Stem Cell Institute, where she led the clinical trials division and implemented programs across multiple disease areas. During this time, she oversaw numerous investigator-initiated clinical trials of novel cell-based therapies for cardiovascular disease, enrolling more than 200 patients, the largest single-center experience of its kind in the United States.

Darcy is also deeply committed to mentorship and professional development, having trained and supported physicians, medical students, nursing students, international nurses, and clinical research professionals throughout her career.