BARDA Senior Pharmaceutical Business Development and Portfolio Management Subject Matter Expert

BryceTech has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision-making. Bryce cultivates a culture of engagement and partnership with our clients. BryceTech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran

Background. In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.  

General SME Responsibilities:

• Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
• Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
• Participate as subject matter experts on Program Coordination Teams (PCTs).
• Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.
• Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.
• Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise. 
• Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work. 
• Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations. 
• Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space. 
• Provide recommendations for project development level portfolio management and oversight as required. 
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.

Senior Pharmaceutical Business Development and Portfolio Management Subject Matter Expert Responsibilities

• Advise the Office of Director on Portfolio Management Decisions.
• Provide financial analysis on medical countermeasure products that have both commercial and bio defense indications, specifically identifying the sustainability / viability of a commercial market.
• Provide financial analysis to BARDA on the impact of proposed economic incentives.
• Support the implementation of enhanced Portfolio Management for BARDA.
• Ensure alignment of Division portfolios with BARDA strategic priorities.
• Evaluate commercial feasibility of a drug development candidate, feasibility of vendor managed inventory and other alternatives to stockpiling MCMs.

• Managing key projects, stakeholders, and personnel, such as biochemical engineers, researchers, scientists, healthcare consultant, and physicians.
• Establishing and maintaining timelines for drug trials and ensuring proper, compliant completion of each one.
• Staying up to date on all applicable regulatory guidelines, like rules from the U.S. Food and Drug Administration.
• Keeping detailed records on the progress of research, trials, and approvals from one phase to the next, in accordance with regulatory mandates and corporate governance rules.
• Evaluating the results of trials and in appropriate cases choosing to halt development due to safety concerns, in efficacy or side effects.

• At least 17 years of Pharmaceutical Business Development and Portfolio Management experience.
• Industry experience evaluating portfolio strength, conducting business analysis, portfolio rebalancing, and performing financial evaluation of BioPharma assets (e.g., calculations).
• Experience evaluating out‐licensing and in‐licensing Drug Development opportunities.
• Experience raising capital (VC, IPO, etc.) to support product development.
• Experience providing strategic planning for BioPharma.
• Experience managing a diverse portfolio of products and development stages (discovery to commercial) that resembles diversity and scale of BARDA portfolio.
• Industry experience preferred with alliance / M&A sourcing experience.
• Understanding of MCM design, R&D, licensing, and use required.
• Experience with development, implementing, and oversight of pharmaceutical portfolio Total Life Cycle Cost (TLCC)

BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.

This position will most likely be 100% remote.