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# Gormley Adds Oncology Endpoint Role at FDA
- URL: https://www.fdaweb.com/gormley-adds-oncology-endpoint-role-at-fda/
- Published: 2022-10-24T12:00:00.000Z
- Updated: 2026-09-14T18:04:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153037

CDER Division of Hematologic Malignancies 2 division director **Nicole Gormley** has been named acting associate director for oncology endpoint development in FDA’s Oncology Center of Excellence. The agency says Gormley will have a dual role, continuing in her capacity as director of the hematology division.

In her new role, Gormley will work closely with external stakeholders, liaisons to Project Endpoint, and other oncology programs to provide guidance on scientific and policy efforts related to early endpoint development in oncology, the agency says.

Gormley joined FDA in 2011 as a clinical reviewer in the Division of Hematology Products. She has served as the current division director since 2019\. An FDA email says she has had an active interest in development of early endpoints, specifically minimal residual disease in hematologic malignancies. “She has represented FDA on numerous projects, external working groups, and publications focused on development of early endpoints,” it says.

Gormley has a degree from the Medical College of Ohio, and completed her residency in internal medicine at the University of Maryland. She also completed fellowship training in hematology and critical care at the National Institutes of Health.

In her new role in the OCE, Gormley will work closely with external stakeholders, liaisons to Project Endpoint, and other OCE programs to provide direction, coordination, and oversight for scientific and policy efforts related to early endpoint development in oncology.