To submit your application, scroll to the bottom of this opportunity and click APPLY.

A complete application consists of:

• An application
• Transcripts – Click here for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in White Oak, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This effort covers more than just medicines.

Research Project: Over 40% adults and 1 in 5 children and adolescents in the United States have obesity and may need a different dosing strategy for medications. The objective of this research project is to investigate optimized dosing for cancer drugs in obese patient populations (adults and pediatrics). The aims are to address gaps in scientific knowledge of cancer drug dosing in obesity, particularly in pediatric patients; understand the pharmacokinetics of oncology drugs in obese patients; and inform regulatory decision-making regarding appropriate dosing, clinical trial design, and labeling of oncology drugs for patients with obesity.

During the appointment you will:

• Engage in comprehensive data analysis of oncology clinical trials to examine dosing, efficacy outcomes, and safety profiles across different body mass index categories, and investigate the relationship between body size (body weight, body mass index, body surface area) and pharmacokinetics/pharmacodynamics in cancer patients.
• Collaborate with FDA scientists to analyze existing clinical trial data, investigate dosing methodologies, and contribute to the development of evidence-based guidance for oncology drug dosing in patients with obesity.
• Gain hands-on experience with data analysis/platforms and knowledge of regulatory science and oncology drug development.
• Participate in Office and Division-level clinical pharmacology training modules/programs.
• Build a professional network within FDA and the broader regulatory science community through collaboration with multidisciplinary teams including clinical pharmacologists, oncologists, and regulatory reviewers.
• Contribute to peer-reviewed publications, scientific presentations at conferences.

Learning Objectives: 

During the appointment you will learn about:

• Clinical pharmacology principles specific to oncology drug development and population-specific (obesity) dosing considerations.
• Analyzing complex clinical trial datasets and applying clinical pharmacology tools/software to address regulatory questions related to dosage optimization of oncology drugs in obesity. Additionally, the participant will gain exposure to clinical trial designs in various patient populations and understand the regulatory implications of dosing recommendations.
• Understanding of FDA's drug review process, particularly regarding clinical pharmacology assessments and dosing recommendations for specific populations.
• Scientific communication, including the preparation of scientific manuscripts and presentations for both internal FDA audiences and external scientific communities.

Mentor: The mentor for this opportunity is Ruby Leong (ruby.leong@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: June 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 only.

This 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.

Completion of 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.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists. 

FDA requires ORISE participants 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.

The qualified candidate should be currently pursuing or have received a bachelor's, master's, or doctoral degree in the one of the relevant fields. 

• Citizenship: U.S. Citizen Only
• Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree.
• Discipline(s):
  • Computer, Information, and Data Sciences (3 )
  • Life Health and Medical Sciences (5 )
  • Mathematics and Statistics (1 )

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.