FDA Biomarker Discovery Postdoctoral Fellowship

*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), located in Silver Spring, Maryland. 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 FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

This project will focus on how to generate and use advanced genomics and other -omic or big data technology, such as next generation sequencing (NGS) and cutting-edge bioinformatics, to evaluate biomarker discovery of drug response and resistance as well as drug-target interactions.

Under the guidance of the mentor, the participant will be trained in next-generation sequencing technologies, genomics and molecular genetics in cell-based systems, small RNA transcriptomics of clinical samples, and bioinformatic and statistical analyses of data resulting from these experiments. This will inform biomarker discovery of drug response as well as drug-target interactions and downstream effects in tissues. This training will prepare the participant for a successful career transition into regulatory science research.

Anticipated Start Date: 2024. The start date is flexible and will depend upon a variety of factors.

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 initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. 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 have received a doctoral degree in one of the related fields. Degree must have been received within the past five years.

Preferred Skills:

• Exposure and familiarity with DNA and/or RNA next-generation sequencing
• RNA/DNA/protein extraction and quantification
• PCR- and RT-qPCR array-based technology
• Genome editing, molecular cloning, and reporter gene assays
• Exposure and familiarity with long read sequencing
• Familiarity with analysis of sequence data, bioinformatics and/or biostatistics