Overview
*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 Silver Spring, 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. These efforts cover more than just medicines.
Research Project: The purpose of this proposed project is to better understand the impact of proteinuria on elimination and PK of biological products to optimize the dose in patients with proteinuria in clinical studies and labeling recommendations. It will help provide guideline on further clinical pharmacology considerations in treatment of patients with proteinuria with biologic products. You will be a part of data collection, analysis, modeling and simulation for this project.
Learning Objectives: Under the guidance of a mentor, you will have the opportunity to learn about drug development, considerations of biologics development in patients with proteinuria, PK/PD analysis, and modeling and simulation.
Mentor: The mentor for this opportunity is Jianmeng Chen (jianmeng.chen@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: November 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 and Lawful Permanent Residents (LPR) 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.
Qualifications
The qualified candidate should be currently pursuing or have received a doctoral degree in the one of the relevant fields (in life science, pharmacy, CS or medicine related field).
Preferred skills:
Analytical, written, and oral communication skills, and have a profound interest in projects that advance regulatory science and public health.
Knowledge in Pharmacokinetics, data mining, data analysis, Pharmacomatrics, Pharmacology, and has software skills such as NONMEM, R or Python, SAS, etc.
Point of Contact
Ashley
Eligibility Requirements
Citizenship: LPR or U.S. Citizen
Degree: Doctoral Degree.
About U.S. Food and Drug Administration (FDA)
FDA's mission is to protect and advance public health by helping to speed innovations that provide our nation with safe and effective medical products and ensure the safety of our food supply, cosmetics, and products that emit radiation.
