*Applications will be reviewed on a rolling basis.
A research opportunity is currently available in the Office of New Drugs (OND)/ Office of Infectious Diseases (OID) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) 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.
Viral infections cause significant illness across the lifespan and around the world. Despite years of drug development for common viruses (e.g., herpes simplex, influenza) and intense collaborative work for emerging viruses (e.g., SARS-CoV-2, ebola), there continue to be many challenges with study design, including selection of endpoints, defining patient populations, and off-label use of drugs considered standard-of-care. The project will analyze results from available clinical trial data and will enable the Division of Anti-Viral to gain new insights about viral diseases and identify clinical trial design elements that can be used to optimize the study of antiviral drugs.
Under the guidance of the mentor, the participant will learn to evaluate key issues that make antiviral drug clinical trials challenging and research that might provide a means to overcome these challenges. The participant will gain an understanding on how the Division of Antivirals leverages available data to address gaps in scientific knowledge. The participant will also gain an understanding of the process of receiving FDA Institutional Review Board approval when using data from various sources.
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.