Pre-Clinical Drug Development Subject Matter Expert (SME)
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 a Pre-Clinical Drug Development SME in pre-clinical antiviral drug development 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:
- Provide subject matter expertise in antiviral drug development, including but not limited to high throughput screening and hit to lead identification, preclinical, clinical, regulatory, and manufacturing.
- Work products related to the development and management of programs within current and planned BARDA medical countermeasures advanced development and acquisition contracts.
Responsibilities are but not limited to:
- Provide virology subject matter expertise in viral pathogenesis and host-pathogen interactions, contributing to identification and evaluation of potential targets for prophylactic and treatment interventions.
- Review in vitro and nonclinical studies of medical countermeasures, with focus on product mechanism of action and safety/toxicology.
- Assess candidate products for scientific feasibility and entrance into the BARDA antiviral portfolio in alignment with BARDA's strategic priorities.
- Provide subject matter expertise in Preclinical through Phase 1 development.
- Further collaboration with the NIAID and other interagency partners in development of antivirals.
Requirements:
- At least fifteen (15) years of relevant industry experience
- Evidence of experience in regulatory strategy, design and execution, and developing regulatory submissions in developing antiviral drug development
- Application of doctoral degree(s) in biology or similar field(s) with commensurate experience(s) in viruses that cause viral hemorrhagic fever (VHF) (e.g., filoviruses, arenaviruses, and pox viruses).
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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