The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest Institutes of the National Institutes of Health (NIH), is seeking exceptional applicants with diverse skill sets in pharmacokinetics and pharmacodynamics to serve as a program officer in the Division of Microbiology and Infectious Diseases (DMID). DMID supports extramural research to control and prevent diseases caused by virtually all human infectious agents (except HIV) and directs a program of research grants and contracts in microbiology and infectious diseases.
As a program officer, you will manage or contribute to clinical protocol design, gap analysis for investigational new drug (IND) filing, oversight of bioanalytical method development and validation, evaluation of preliminary pharmacokinetic data, and simulation and modeling of early data in support of follow-up studies. The candidate will serve in the Office of Regulatory Affairs to provide support to ensure the safety and efficacy of target product candidates (vaccines and therapeutics). This position is integral in providing support for strategic development plans for planned clinical trials. These clinical trials involve collaboration across all program branches of DMID, including but not limited to Respiratory Diseases, Bacteriology and Mycology, Parasitology, Virology, Enteric and Hepatic Diseases, Sexually Transmitted Diseases, and the Office of Biodefense, Research Resources, and Translational Research. This program officer position is critical to the division in ensuring that clinical studies are done in a manner that will be acceptable to the FDA and can be used to support product licensure.
Candidates must be U.S. citizens and demonstrate that they have worked independently in planning, organizing, and conducting biomedical behavioral health or health-related research as well as served effectively in research program administration in these fields.
Clinical pharmacokineticists with clinical and regulatory expertise in clinical drug and/or vaccine development and drug and vaccine safety are preferred.
Candidates with the following experience and skills are desired:
Expertise in Phase 1 clinical trial design, dose, and dose escalation selection, and protocol development and implementation
Clinical and nonclinical pharmacokinetic analysis, modeling, and simulations
PK software (Phoenix WinNonlin, NLME, NONMEM)
Pharmacokinetics for projects under "Animal Rule" provision
Design and execution of nonclinical toxicology studies in support of vaccine, macromolecule, and small molecule development
Bioanalytical assay development and validation
Solid understanding of good laboratory practices (GLP) and good clinical practices (GCP) regulations
Pre-IND and IND filings
Responsible for regulatory preparation of data for submission and presentations at the FDA Advisory Committee
Visit USAJobs.gov and access the health scientist administrator/program officer vacancy announcements NIH-GR-DH-21-10999306 (U.S. citizens) and/or NIH-GR-DH-21-10999307 (status candidates) from January 18 – 27, 2021.