Sr Therapeutic Development 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 a Sr Therapeutic Development Subject Matter Expert 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 all aspects of influenza and emerging infectious disease antiviral and host-targeted drug development, including but not limited to high throughput screening and hit to lead, preclinical, clinical, regulatory, and manufacturing.
  • Work products related to the development and management of regulatory studies and licensure programs within current and planned BARDA therapeutic development and acquisition contracts.

Responsibilities are but not limited to:

  • Support BARDA Program Office(s) as a subject matter expert in therapeutic advanced development including clinical, regulatory policy, development feasibility and marketability of therapeutic candidates.
  • Provide guidance documents and option papers on key issues related to the area(s) identified.
  • Review contract proposal and related documents.
  • Provide senior-level briefing(s) to ASPR/BARDA as required; Prepare regular reports to ASPR/BARDA management on various technical issues identified.
  • Provide project development level portfolio management and oversight.
  • Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts

Requirements:

  • At least fifteen (15) years of relevant industry experience
  • Application of doctoral degree(s) in medicine or pharmacy with commensurate experience(s).

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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