Director, Office of Clinical Research Affairs (OCRA)
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Department of Health and Human Services (HHS)
The National Institute of Allergy and Infectious Diseases (NIAID) is seeking an exceptional and visionary leader for the position of director, Office of Clinical Research Affairs (OCRA), Division of Microbiology and Infectious Diseases (DMID). DMID is the lead NIAID extramural division responsible for research on all infectious human pathogens (other than HIV) and all infectious diseases (other than AIDS), including biodefense. DMID has taken on a critical role as the lead component of the National Institutes of Health (NIH) in efforts to develop countermeasures for potential agents of bioterrorism and emerging infectious diseases.
DMID’s clinical research program has grown exponentially to comprise numerous clinical trial networks and an extensive portfolio of clinical research and interventional clinical trials evaluating vaccines, diagnostics, and therapeutics. In addition to a robust general infectious diseases clinical research program, DMID has an aggressive biodefense research program to develop diagnostics, vaccines, and treatments to protect the U.S. population. A large focus of the DMID biodefense program is advanced product development with a concomitant goal-oriented, milestone-driven critical clinical development path.
The director, OCRA, serves as a key advisor to DMID leadership on all clinical research issues and performs a wide variety of duties and responsibilities related to the implementation of clinical studies. Responsibilities for this position include overseeing the design, conduct, and evaluation of DMID-supported domestic and international clinical trials; oversight of clinical trial networks; providing advice on new initiatives and directions with respect to clinical research; ensuring compliance of DMID extramural clinical research with Government policies, regulations, and guidelines; consulting with voluntary and professional health and research organizations, pharmaceutical and biomedical industries, and other groups as needed to identify and meet clinical research needs.
The director must facilitate implementation of trials in challenging circumstances, including time-sensitive protocols, large multicenter and multicountry trials (such as phase 3 trials), and trials in non-typical sites. Many research projects are of broad and complex scope to treat problems that are exceptionally difficult and may require unconventional/novel approaches or complex research techniques. The director must identify and resolve a variety of complex clinical trials management, policy, and administrative issues that require close coordination and collaboration with other programs at NIAID, NIH Institutes, federal agencies, pharmaceutical companies, and patient advocacy and community groups.
Applications must have an M.D. and expertise (fellowship trained) in infectious diseases. In addition, the candidate must have demonstrated skills in the following:
1. Overseeing and conducting clinical trials as a principal investigator of registrational/Investigational New Drug trials
2. Detailed knowledge of clinical research and clinical trial oversight, and sponsor responsibilities
3. Experience with US government funding mechanisms (grants and contracts) and oversight
4. Experience working with multicenter networks to implement clinical trials
5. Detailed knowledge of clinical trial processes and procedures as well as relevant regulatory issues and standards
Salary is commensurate with experience, and a full package of benefits is available, including retirement, health and life insurance, long-term care insurance, leave, and a Thrift Savings Plan (401k equivalent).
Visit USAJobs.gov and access the detailed vacancy announcement #NIH-NIAID-DH-23-11758096 beginning March 10, 2023. Applications must be submitted online by 11:59 p.m. on March 14, 2023. All information provided by applicants will remain confidential and will be reviewed only by authorized officials of NIAID.
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