*Applications will be reviewed on a rolling- basis.
FDA Office and Location: A research opportunity is available in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Food and Drug Administration (FDA) located in Silver Spring, Maryland. This is a collaborative research project in the Center for Drug Evaluation and Research (CDER).
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 work covers more than just medicines.
Research Project: The research project will use model-informed drug development approaches, such as population pharmacokinetic modeling, pharmacokinetic- pharmacodynamic modeling, and clinical trial simulations and genomic marker assessment for regulatory research. Example areas of research include using model-based approaches for characterizing and analyzing the demographic data from clinical trials conducted for the FDA approved products to address the importance of racial and ethnic diversity in oncology clinical studies as well as its implications as it relates to the distribution of oncology genomic markers. As part of this opportunity, the participant will participate with a multi-disciplinary team to help in identifying the key limitations in past oncology drug approvals support regulatory recommendations that leverage all available data to address racial and ethnic disparities in clinical studies.
Learning Objectives: Under the guidance of a mentor, the participant will learn about designing clinical studies, designing analysis plans, and assessing oncology genomic markers and conducting quantitative analysis on clinical study data to evaluate impact of racial and ethnic diversity on drug exposure and biomarkers (e.g., PD and genomic) of cancer drug products. Participant will also learn to prepare a database describing information gathered from multidisciplinary regulatory reviews completed during clinical development and following submission of the marketing application and publicly available sources, including published literature and compendia. The quantitative analysis will include, but is not limited to, pharmacokinetic/pharmacodynamic modeling, non-compartmental analysis, and statistical modeling. In addition, the participant will be given the opportunity to write and publish scientific manuscripts and present findings internally and externally.
Anticipated Appointment Start Date: 2024/2025. 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
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.
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.
