CDER Fellowship in Natural History for Rare Pediatric Viral Disease

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available in the Office of Infectious Diseases (OID), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) 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 work covers more than just medicines.

Research Project: This project awards an opportunity to join two ongoing studies evaluating rare pediatric diseases caused by viral infections. In the first study, the participant would join the FDA study team to analyze data collected from retrospective chart reviews at 10 large pediatric transplant centers in the United States. The goal of this study is to describe the natural history and current management of adenovirus (AdV) infections, a cause of severe illness in children undergoing hematopoietic stem cell transplantation (HSCT). We aim to a) characterize the clinical outcomes of pediatric AdV infection in HSCT patients, including the incidence of documented AdV disease, all-cause mortality, and AdV-related mortality, b) improve our understanding of how AdV viral loads correlate with clinical outcomes, and c) improve our understanding of how various treatment strategies (including antiviral drugs, immunotherapy, changes in immunosuppression) impact clinical outcomes.

In the second study, the participant would join the FDA study team to analyze retrospective data obtained from electronic health records of children with congenital cytomegalovirus (cCMV) infection. The goals of this study are to; a) determine patterns of antiviral treatment for infants with cCMV in the United States b) evaluate the impact of safety events and clinical response to the duration of antiviral treatment course and c) obtain insights for possible endpoints, including biomarkers (e.g. CMV viral load) that might help future study designs.

Learning Objectives: Under the guidance of the mentor, the participant will; gain experience with the format and structure of Real-World datasets, build on prior skills with database formation and data analysis to critically analyze data, hone communication skills by sharing results in oral and written format, learn how the results impact future development of antiviral drugs, understand FDA's role in addressing areas of unmet medical need, learn about the natural history of two rare pediatric diseases, and the impact of these illnesses on patients and their families.

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.

Qualifications

The qualified candidate should be currently pursuing or have received a bachelor's or master's in biological sciences or epidemiology. Degree must have been received within five years of the appointment start date or anticipated to be received by 6/28/2024.

Ability to program in R and/or SAS and knowledge in statistics is preferable.

Eligibility Requirements

• Degree: Bachelor's Degree or Master's Degree received within the last 60 months or anticipated to be received by 6/28/2024 12:00:00 AM.
• Academic Level(s): Graduate Students, Post-Associate's, Post-Bachelor's, Post-Master's, or Undergraduate Students.