Full-Time BARDA Senior Vaccine SME

Background: In 2006, the Biomedical Advanced Research and Development Authority (BARDA) was established to support vaccine, therapeutic, diagnostic, and innovative technology development during public health emergencies.

BARDA's Success: BARDA has supported over 60 FDA approvals, 101 Biomedical products for COVID-19, and 136 COVID-19 partnerships.

General SME Responsibilities:

• Support BARDA Program Offices as a subject matter expert (SME) in chemical, radiological/nuclear, burn/blast injuries, or biological threats.
• Support Influenza and Emerging Infectious Diseases Division (IEIDD).
• Manage research, development, manufacture, and regulatory approval/licensure/clearance of medical countermeasures.
• Provide guidance and recommendations on key issues.
• Serve as advisor on Technical Evaluation Panels (TEPs).
• Participate in Program Coordination Teams (PCTs).
• Provide expert assessments, recommendations, and guidance.
• Develop work products (reports, analysis).
• Advise federal staff on contractor proposals.
• Distill complex information into concise summaries.
• Participate in strategic discussions.
• Provide recommendations for project development level portfolio management and oversight.
• Provide recommendations on Total Life Cycle Cost (TLCC) efforts.
• Participate in Market Research.

Senior Vaccine and Biologic Development SME Responsibilities:

• Apply expertise to regulatory studies and licensure programs.
• Supervise less experienced SMEs.
• Serve as primary interface with BARDA and Industry Senior Leadership.
• Coordinate with program managers, scientists, and other SMEs.
• Evaluate vaccine candidates.
• Evaluate raw data.
• Make recommendations to facilitate decision-making.
• Review contract proposals.
• Provide senior-level briefings.
• Prepare regular reports.
• Draft briefings on technical alternatives.
• Provide project development-level portfolio management and oversight.
• Provide support to BARDA’s Production Coordination Teams.
• Provide and summarize guidance documents.
• Develop milestones, targets, and metrics.
• Accelerate information flow from senior leaders.
• Facilitate coordination across entities.
• Serve as programmatic representative at conferences and stakeholder meetings.
• Provide scientific/technology advice, technical oversight, and project management support.
• Collaborate with internal and external partners.
• Engage in open and collaborative communication at conferences.
• Develop/review technical documentation (reports, procedures, submissions).
• Prepare/review protocols and study plans.
• Assist with identifying and assessing risks.

Qualifications:

• Doctoral degree in medicine or pharmacy.
• 15+ years of relevant experience.
• 10+ years of industry experience in pharmaceutical/biotechnology advanced development.
• Experience in pharmaceutical/biotechnology drug development portfolio management.
• Experience in regulatory studies and licensure programs.
• Experience guiding multiple planning lines of effort.
• Published peer-reviewed articles (preferred).

Benefits: Competitive salary, comprehensive health plan, life & disability insurance, 401(k) plan, educational reimbursement.

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