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FDA Fellowship - Characterizing Use of Artificial Intelligence to Substantiate Evidence of Effectiveness and Safety Information for Approved CDER Products

Oak Ridge Institute for Science and Education · White Oak, MD · 1 mo ago
OTHRFull-time

Research Project

Analyze CDER approval packages (NDAs/BLAs) from 2016–2026 to characterize how AI has been used to substantiate evidence of effectiveness and safety information in drug and biologic approvals.

Build an interactive, queryable dashboard (e.g., Power BI) to track and monitor historical and incoming AI use cases, prioritizing those with the highest regulatory impact.

Translate findings into draft training materials, seminars, and capacity-building resources to standardize FDA reviewer feedback and upskill CDER staff on AI in drug development.

Disseminate findings to the broader scientific and regulatory community via peer-reviewed manuscript, white papers, and conference presentations, etc.

Learning Objectives

  • Develop proficiency in systematically reviewing and evaluating AI model characteristics, outputs, and their evidentiary role in CDER drug and biologic approval decisions.
  • Gain hands-on experience designing and deploying an operational database or interactive dashboard to track, query, and analyze AI use cases in regulatory submissions.
  • Become experienced in translating complex regulatory and scientific findings into accessible training materials, peer-reviewed manuscripts, and conference presentations for both internal FDA audiences and the broader scientific community.

Mentor

The mentor for this opportunity is Gabriel Innes (gabriel.innes@fda.hhs.gov).

Anticipated Appointment Start Date

September 1, 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation

The appointment is full time.

Participant Stipend

The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

Program Information

The program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Background Investigation

A successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

ORISE Education and Training Agreement

The ORISE fellow’s obligation to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:

  • Non-employee nature of the ORISE appointment;
  • Prohibition on ORISE Fellows performing inherently governmental functions;
  • Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
  • The fact that research materials and laboratory notebooks are the property of the FDA;
  • ORISE fellow’s obligation to protect and not to further disclose or use non-public information.

Qualification Requirements

The qualified candidate should be currently pursuing or have received a master's degree in one of the relevant fields. Degree must have been received within five years of the appointment start date or be currently pursuing.

Preferred skills/ knowledge:

  • Skills in at least one programming language (e.g., Python, R)
  • Analytical skills

Discipline(s):

  • Life Health and Medical Sciences (51)

I am a U.S. citizen; or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)

AND

I have read the FDA Ethics Requirements.

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