Full-Time BARDA Senior Pharmaceutical SME
BryceTech is hiring a remote Full-Time BARDA Senior Pharmaceutical SME. The career level for this job opening is Expert and is accepting Washington, DC based applicants remotely. Read complete job description before applying.
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Background. BARDA (Biomedical Advanced Research and Development Authority) was established to support the development of vaccines, therapeutics, diagnostics, and innovative technologies for public health emergencies. BARDA's success includes over 60 FDA approvals, licenses, and clearances, 101 Biomedical products supported for COVID-19 response, and 136 BARDA-supported COVID-19 partnerships. This success relies on public-private partnerships accelerating the development of Medical Counter Measures (MCMs) vital to national security. BARDA supports partners with capability, technical support, advanced research & development (AR&D), FDA licensure, and clinical use to accelerate MCM regulatory approval and deployment.
General SME Responsibilities: Support BARDA Program Offices as a subject matter expert in Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (viral/bacterial). Expertise includes research, development, manufacture, and regulatory approval of MCMs (diagnostics, devices, vaccines, and therapeutics).
Desired experience: medicinal chemistry, preclinical development, advanced clinical development, analytical product testing, quality control, clinical/regulatory policy, manufacturing (chemistry, manufacturing, and controls), process development, device development, reliability engineering, software, assay chemistry, microbiology, virology, immunology, plastic consumable design & manufacturing. Experience in manufacturing scalability, capacity expansion, sterile/aseptic techniques, sterile manufacturing/filling, and sterile facilities (sterile gowning) is required.
Advisory Roles: Advise on Technical Evaluation Panels (TEPs), including white papers/market research, technical proposals, and budget proposals. Participate as subject matter experts on Program Coordination Teams (PCTs). Provide expert assessments, recommendations, and guidance to PCTs and CORs as needed.
Expert Support: Provide subject matter expertise and advisory support to federal staff for program cost estimations. Review study protocols, reports, regulatory documents, presentations, proposals. Develop work products like expert summary reports, analysis reports, manuscript writing/contributions. Advise federal staff on the appropriateness and probability of success of contractor statements of work and suggest improvements.
Strategic Discussions: Distill complex information into concise summaries, risk/benefit analyses, and recommendations. Participate in strategic discussions, working with USG, to build new program areas aligned with BARDA’s mission. Provide recommendations for project development, portfolio management and oversight. Provide recommendations or advise on development, implementation, and improvement of Total Life Cycle Cost (TLCC) efforts. Participate in market research efforts.
Senior Pharmaceutical Business Development & Portfolio Management Responsibilities: Advise the Office of Director on Portfolio Management decisions. Conduct financial analysis of MCM products with both commercial and biodefense indications, focusing on market sustainability/viability. Analyze the impact of proposed economic incentives.
Portfolio Management: Support the implementation of enhanced Portfolio Management for BARDA, ensuring alignment of division portfolios with BARDA strategic priorities. Evaluate commercial feasibility of drug development candidates, vendor-managed inventory, and alternatives to MCM stockpiling.
Project Management: Manage key projects, stakeholders, and personnel (biochemical engineers, researchers, scientists, consultants, physicians). Establish and maintain timelines for drug trials, ensuring compliant completion. Stay updated on all FDA guidelines.
Regulatory Compliance: Maintain detailed records on research, trials, and approvals. Evaluate trial results, potentially halting development due to safety or efficacy concerns.
Experience Requirements: Minimum 17 years of pharmaceutical business development and portfolio management experience. Industry experience in portfolio strength evaluation, business analysis, portfolio rebalancing, and financial evaluation of BioPharma assets (out-licensing/in-licensing). Experience in capital raising (VC, IPO) for product development, strategic planning for BioPharma, and managing diverse product portfolios (discovery to commercial) is required. Understanding of MCM design, R&D, licensing, and use is necessary. Experience with development, implementation, and oversight of pharmaceutical portfolio TLCC is preferred. Alliance/M&A sourcing experience is also desirable.
Benefits: Competitive salary, health (dental/vision) plan, company-paid life/disability insurance, 401(k) plan with match, and educational reimbursement.
Work Environment: 100% remote.