FDA Quantitative Systems Pharmacology Modeling Fetal Cardiac Safety Fellowship

How To Apply

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U.S. Food and Drug Administration (FDA)

FDA-CDER-

• An application
• Transcripts –  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. Please include the reference code for this opportunity in your email.

6/19/2026 3:00:00 PM Eastern Time Zone

• Applications will be reviewed on a rolling-basis.

A research opportunity is available at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) Office of Immunology and Inflammation (OII), 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. This effort covers more than just medicines.

Congenital heart defects (CHDs) are a significant public health concern, with potential long-term implications for affected individuals. Studies have identified a possible association between the use of antidepressants during pregnancy and an increased risk of CHDs in offspring. Studies in cells and animals have suggested that heart defects might be related to disruption of maternal serotonin levels in the fetus which plays a key role in cardiac morphogenesis.

Serotonin promotes the growth of fetal heart cells while abnormal or blocked serotonin levels can change heart development. Understanding the mechanisms responsible for this association is crucial for developing effective prevention strategies and minimizing potential risks associated with serotonin modulating drugs used in pregnancy.

Predictions from our QSP model will strengthen associations between drugs and outcome which can lead to interventions that minimize the risk and potentially the incidence of CHD. One potential intervention is screening for genetic polymorphisms in important proteins identified in this pathway; screening interventions can be done earlier than fetal ultrasounds. Therefore, this research has the potential to reduce the incidence of congenital cardiac anomalies and improve the long-term outcomes for affected individuals and their families.

There is also a potential to uncover novel therapeutic targets and interventions to minimize the risk of congenital cardiac anomalies. In turn this project will advance safety and understanding of potential toxicity of FDA-regulated products in the perinatal population.

Under the guidance of the mentor, you will gain experience in literature searches and curating datasets. You will also learn basic principles of clinical pharmacology, maternal-fetal medicine, and PK/PD/QSP modeling and simulation methods. Subsequently, you will learn how to effectively communicate their findings and answer questions about their research. You will advance their career by gaining new skill sets in clinical pharmacology, scientific and computational research and communicating scientifically.

• Understanding and extracting relevant data from the literature and synthesizing available studies to develop a computation model
• Introduction to clinical pharmacology and maternal-fetal medicine
• Building upon participants knowledge of ODE-based modeling and simulation methods using R programming
• Effective communication of scientific studies

The mentor for this opportunity is Blessy George (Blessy.

George.gov). If you have questions about the nature of the research, please contact the mentor.

June 2026. Start date is flexible and will depend on a variety of factors.

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

The appointment is full-time.

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

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…