About Dr. Gormley
A career built at the center of oncology regulation.
Dr. Nicole Gormley is a physician, regulatory scientist, and former FDA Division Director, whose career was defined by consequential decisions at the highest levels of oncology drug review.
She founded Gormley Advisory with the goal to help bring safe and effective therapies to patients as expeditiously as possible. Rigorous regulatory science and meaningful patient access are not competing priorities, they are the same goal, pursued through better decisions made earlier in development.
Full Biography
Former Division Director, Hematologic Malignancies II, CDER
Dr. Gormley joined the agency in 2011 and advanced through successive leadership roles before being appointed Division Director of Hematologic Malignancies II in 2019, a position she held until 2026.
In that role, she carried signatory authority for NDA and BLA decisions across multiple myeloma, lymphoma, bispecific T-cell engager programs, and other immuno-oncology therapeutics, leading a division of approximately 25 physicians through some of the most active and complex periods in hematologic malignancy drug development.
From 2022 onward, she served concurrently as Associate Director for Endpoint Development at the Oncology Center of Excellence, a role that placed her at the intersection of regulatory science, policy, and evolving standards for oncology programs across all indications.
Earlier Career
Before her regulatory career, Dr. Gormley completed dual fellowship training in Hematology and Critical Care Medicine at the National Heart, Lung, and Blood Institute at the NIH, where she also served as Deputy Clinical Director. She is board-certified in Internal Medicine, Hematology, and Critical Care Medicine.
Research & Publications
She has authored more than 50 peer-reviewed publications on oncology drug approvals, MRD methodology, novel endpoint development, immunotherapy combinations, and health equity in clinical trials, and has been a featured speaker at major oncology and regulatory science conferences.
Education
M.D.
Medical College of Ohio
B.A.
Cornell University
Would your program benefit from expert strategic advice?
Dr. Gormley works with a limited number of clients at any one time. This is a deliberate choice, the quality of judgment this practice offers depends on genuine engagement with each program, not volume.
A complimentary 30-minute introductory call to assess fit.
