Full-Time BARDA Pharmaceutical Business Development and Portfolio Management SME
BryceTech is hiring a remote Full-Time BARDA Pharmaceutical Business Development and Portfolio Management SME. The career level for this job opening is Experienced and is accepting Washington, DC based applicants remotely. Read complete job description before applying.
BryceTech
Job Title
Posted
Career Level
Career Level
Locations Accepted
Share
Job Details
General SME Responsibilities: Support BARDA Program Office(s) as a subject matter expert in Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats. Includes viral and bacterial threats, Influenza, and Emerging Infectious Diseases. Expertise required in research, development, manufacture, and regulatory approval of medical countermeasures (diagnostics, medical devices, vaccines, therapeutics).
Desired Experience Areas: Medicinal chemistry, preclinical development (animal models, pharmacology, toxicology), advanced clinical development (medical officers, immunologists, clinical operations), analytical product testing, quality control, clinical and/or regulatory policy, manufacturing (chemistry, manufacturing, and controls), process development, scale-up, optimization, device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology, Plastic consumable design and manufacturing. Experience in manufacturing scalability, capacity expansion, sterile/aseptic technique, sterile manufacturing, sterile facilities (sterile gowning).
Advisory Roles: Provide guidance, recommendations on key issues, advise on Technical Evaluation Panels (TEPs), participate on Program Coordination Teams (PCTs), provide expert assessments, recommendations, and educational materials. Provide subject matter expertise to federal staff for cost estimates for programs. Review and comment on study protocols, reports, regulatory documents, presentations, proposals, and related documents.
Work Products: Develop expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, review and technical assessments of BARDA documents. Advise federal staff on contractor proposals and make suggestions for improvement. Distill complex information into concise summaries, including risk/benefit analyses and recommendations. Participate in strategic discussions. Provide recommendations for project development, portfolio management, oversight. Recommend Total Life Cycle Cost (TLCC) efforts. Participate in market research.
Specific BD and Portfolio Management Responsibilities: Advise the Office of Director on Portfolio Management Decisions. Analyze financial impact of medical countermeasures (commercial and bio defense indications). Provide financial analysis on the impact of economic incentives, support enhanced Portfolio Management, ensure alignment of division portfolios with BARDA strategic priorities. Evaluate the commercial feasibility of drug development, vendor-managed inventory, alternatives to stockpiling medical countermeasures.
Experience Requirements: At least 12 years of Pharmaceutical Business Development and Portfolio Management experience. Experience evaluating portfolio strength, business analysis, portfolio rebalancing, financial evaluation of BioPharma assets. Experience in out-licensing/in-licensing Drug Development opportunities, raising capital (VC, IPO), strategic planning for BioPharma, and managing a diverse product portfolio (discovery to commercial).
Additional Requirements: Understanding of MCM design, R&D, licensing, use. Experience with development, implementation, and oversight of pharmaceutical portfolio TLCC.