The purpose of the Oncology Center of Excellence (OCE) Fellows Program is to familiarize fellows training in hematology and/or oncology, pediatric hematology/oncology, or radiation oncology residents with the role of the FDA throughout all phases of oncology drug or biological product development and research. Fellows/residents will gain professional experience under the mentorship of Medical Officers in the Office of Hematology and Oncology Products within the Center for Drug Evaluation and Research. Fellows/residents will also have the opportunity to interact with scientists dedicated to cancer research and product review in the Center for Biologic Evaluation and Research (cellular and gene therapies, vaccines) and the Center for Devices and Radiologic Health (in vitro diagnostics, therapeutic devices).

The key learning objectives for this rotation are:

• Understand the different types of FDA submissions (INDs, BLAs and NDAs).
• Understand the considerations involved in clinical trial design across drug development, including the role of biomarkers and patient-reported outcomes.
• Understand the regulatory requirements for drug approvals, expedited programs and expanded access programs.
• Understand the clinical considerations involved in risk-benefit analysis.
• Understand the role of the OCE in fostering collaboration between FDA Centers.
• Gain understanding about cancer research outreach activities by members of the OCE and key ongoing initiatives critical to cancer research and development.

Hematology and oncology fellows, pediatric hematology/oncology fellows, and radiation oncology residents currently enrolled in an ACGME accredited fellowship/residency program may apply for this 4-8 week program. Rotations are offered three times a year: February-March, May-June, and September-October. Approval from the fellowship/residency program director and a background check are required. This is a volunteer-based program. FDA will not provide transportation or housing.

We are now accepting applications for the following rotations (deadlines are provided below):

Interested?

• Submit a one-page personal statement, your resume, and a brief statement from your fellowship program director in support of your application to [email protected].
• In the subject line of your email, indicate what rotation length and dates you are interested in.
• In your personal statement, explain how this rotation will fit in with your career plans and include your specific area(s) of interest within malignant hematology or oncology (e.g., breast cancer, GI cancers, malignant hematology, etc.).
• This program is only open to United States citizens and permanent residents (green card holders).