BARDA Pharmaceutical Portfolio Management SME

Company Description

BryceTech. BryceTech has partnered with technology and R&D clients to deliver mission and business success for nearly 20 years. 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. Bryce Space and Technology is an Equal Opportunity Employer.

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.

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.  

Job Description

Subject Matter Expert Responsibilities – General

• 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) as well as the research, development, manufacture and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics, preventives, and therapeutics.
• Provide guidance and recommendations on key issues related to the area(s) identified above.
• Review study protocols, study reports, regulatory documents, presentations, proposals, 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 as required.
• Provide recommendations for project development level portfolio management and oversight as required.
• Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.
• Participate in Market Research efforts.

Pharmaceutical Portfolio Management SME 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.

Qualifications

• At least ten to fifteen (10-15) 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.