Program / Technical Advisor

Position Overview: Provides senior-level scientific and technical expertise supporting BARDA's strategic planning and execution of medical countermeasures development programs. Serves as technical authority for complex program areas and provides expert consultation to BARDA leadership on advanced development, regulatory strategy, and portfolio management.

Key Responsibilities:

Expert Technical Advisory & Leadership:

• Provide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses
• Lead Technical Evaluation Panels (TEPs) including evaluation of white papers/market research abstracts, technical proposals, and budget proposals
• Lead Program Coordination Teams (PCTs)
• Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR, as needed
• Provide expert guidance and recommendations on key issues related to medical countermeasure development
• Serve as technical lead for assigned program areas (vaccines, therapeutics, diagnostics, non-pharmaceutical interventions)
• Act as senior SME on scientific subjects

Strategic Program Development:

• Provide senior advisory support to BARDA Program Division(s)
• Lead preparation of draft work statements (SOW, SOO, PWS, IGCE & Cost Estimates) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al]
• Lead strategic discussions, working with USG, in building new program areas in alignment with BARDA's mission space
• Provide expert recommendations for project development level portfolio management and oversight as required
• Lead recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts
• Lead and direct Market Research efforts
• Support strategic planning and portfolio management activities
• Support business case development and cost-benefit analysis for medical countermeasures
• Contribute to "Blue Ribbon" panels and expert working groups

Expert Technical Analysis & Regulatory Leadership:

• Lead analysis of protocols, study reports, regulatory documents, presentations, proposals, and related documents, as needed
• Provide expert-level advanced services including: data cleaning, data transfers, data quality control, data integration and validation, data analysis and report package preparation, statistical simulation, statistical toolbox for advanced data modelling, tabulation, and visualization
• Provide expert ad hoc statistical support to BARDA projects
• Direct complex tasks and lead major technical efforts and scientific projects
• Lead technical interactions with FDA regarding regulatory pathways and requirements
• Serve as technical representative in meetings with industry, academia, and government partners
• Support development of technical requirements for Project BioShield acquisitions
• Provide technical input to acquisition strategies and source selection activities
• Support surge technical expertise during public health emergencies
• Contribute to interagency coordination on medical countermeasures issues
• Mentor junior and mid-level technical advisors
• Additional duties related to programmatic support for MCM may be assigned

Experience:

• Minimum of twelve (12) years of relevant industry experience

Waiver Provision:

• Waiver may be issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG with a minimum of five years (260 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM)

Knowledge & Skills:

• Expert understanding of 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 technique, sterile manufacturing/filling and sterile facilities (sterile gowning)
• Demonstrated expertise in medical countermeasure development (vaccines, therapeutics, diagnostics)
• Deep knowledge of FDA regulatory requirements and drug development pathways
• Experience with advanced development stages (Phase 2/3 clinical trials, licensure)
• Strong understanding of GLP, GMP, GCP standards and quality systems
• Experience with federal R&D programs (NIH, BARDA, DTRA, DoD) preferred
• Proven track record of scientific leadership and strategic thinking
• Excellent communication skills with ability to brief senior leadership
• Experience in emergency response or biodefense programs highly desired
• Board certification or advanced professional credentials preferred

Security Clearance: Public Trust (NACI); Tier 3 (MBI/LBI) or Secret clearance may be required based on assignment

Work Location: Hybrid - Constitution Center, Washington DC / Telework

Work Schedule: 40 hours per week; must support ASPR core hours (9:30 AM - 3:30 PM EST)

Job Type: Contract

Pay: From $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: Remote