Immunology Subject Matter Expert (SME)

Full Time
Washington, DC 20515
Posted
Job description

Advanced Decision Vectors, LLC (ADV), established in 2009, provides superior program management, program support, strategic planning, and systems engineering to the Federal and Commercial sectors. Located in Alexandria, Virginia, ADV is a Small Disadvantaged Business (SDB) contractor that has roots established in the Department of Defense and support agencies. At ADV, our company values are Integrity, Distinction, Experience and Achievement.

Advanced Decision Vectors, LLC (ADV) is seeking an Immunology Subject Matter Expert (SME) to provide contracted support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. The mission of BARDA is to develop and procure medical countermeasures (MCM) that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security.


Deliverables are:

  • Evaluation of host -directed therapeutics and other host-based approaches being developed by BARDA contracted partners, evaluation and assessment of product candidates/companies that engage with BARDA.
  • Assist in structuring of appropriate clinical trial designs, maintaining a current understanding of challenges in advanced product development and potential mitigation approaches, and be versed in current landscape of product candidates in development.
  • Support BARDA DRIVe project management and contribute to strategic direction/implementation of new programs relevant to this expertise.

Responsibilities are but not limited to:

  • Provide expertise in host-directed therapeutic (including drugs, biologics, medical devices, etc.) development with an understanding of host-pathogen mechanisms of action, host (including immune response) to infection, complex host biological pathways and insight into the novel regulatory paths required for host directed products.
  • Expertise for host-based diagnostic product development.
  • Support strategy, design and implementation of studies that provide evidence of clinical utility, including real world evidence outcomes of such novel products.

Requirements:

  • PhD or Medical Degree in Immunology, biology or similar field.
  • Ten (10) to fifteen (15) years of relevant industry or commensurate professional experience in clinical development, immunology, epidemiology, public health, virology, microbiology or medicine.
  • Familiarity with hospital administration and resources in order to launch such clinical studies and should have an understanding of considerations for various clinical settings (pre-hospital, hospital, at home/recovery), including clinical workflows.

ADV employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to such exceptions as required by law. If a covered exemption is requested, it must be approved by our government customer and in line with contractual terms and conditions. You will be required to be vaccinated against COVID-19 and submit documentation of proof of vaccination, if selected.

We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability or veteran status

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