FDA Postdoctoral Fellowship - Impact of Proteinuria on Elimination of mAb

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 33,000 - 45,000; Full time

Job summary

Food and Drug Administration (FDA) in Silver Spring, MD invites qualified doctoral candidates for a full-time research opportunity with CDER. The project studies proteinuria impact on elimination and PK of biologics, involving data collection, analysis, and modeling.

Under mentor Jianmeng Chen you will learn drug development, PK/PD considerations for biologics, and regulatory science relevant to public health in a mentoring setting.

Qualifications

• Pursuing or has doctoral degree in life science, pharmacy, CS or medicine-related field.

Responsibilities

• Data collection, analysis, modeling and simulation for this project.

Skills

Analytical skills

Written communication

Oral communication

Pharmacokinetics

Data mining

Data analysis

Pharmacometrics

Pharmacology

NONMEM

R

Python

SAS

Education

Doctoral Degree

Tools

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0163

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

Application Deadline

12/4/2026 3:00:00 PM Eastern Time Zone

Description

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 ([e-mail]). 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.
• Discipline(s):
• Computer, Information, and Data Sciences (Artificial Intelligence (including Robotics, Computer Vision, Human Language Processing, and Machine Learning))
• Computer Architecture and Grids
• Computer Science - Languages and Systems
• Computer Science - Theoretical Foundations
• Computer Science (general)
• Computer Systems Analysis
• Computer Systems Design (including Signal Processing)
• Data Science
• Databases, Information Retrieval, and Web Search
• Graphics and Visualization
• Human Computer Interaction
• Information Science and Technology
• Information Security and Assurance
• Networks and Communications
• Operating Systems and Middleware
• Scientific Computing and Informatics
• Software Engineering
• Engineering (2 )
• Life Health and Medical Sciences (20 )
• Mathematics and Statistics (7 )

Affirmation

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.)