BARDA Regenerative Medicine Sciences and Medical Product Development SME

Company Description

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

Job Description

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.  

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.

Regenerative Medicine Sciences and Medical Product Development SME Specific Responsibilities.

• Serve as consultant SME in biological and regenerative Sciences and Medical Product Development for Burns, trauma & Critical Care.
• SME would support BARDA in development of therapeutic and medical device candidates indicated for the treatment of initial care of surgical trauma as anticipated during a mass casualty incident.

• Serve as a regenerative medicine/skin and wound-healing consultant to BARDA in support of the development of therapeutic and medical device candidates indicated for the treatment of chemical and radiation burns.
• Provide support to BARDA/Contractor Project Teams for the assigned projects.
• Assist in the design of animal and clinical protocols for the evaluation of efficacy and safety of the assigned therapeutic or device.
• Reviewing Contractor (Sponsor) study reports, regulatory documents, project plans and other technical documents for the assigned projects.
• Review of pharmacology, toxicology, clinical and other sections of regulatory submission.
• Experience with related technologies such as scaffold design, matrix synthesis and degradation, angiogenesis, and inflammation is desirable.
• Experience managing program/projects, including implementation and reporting of preclinical studies and analytical characterization activities.
• Broad-based knowledge of biologics, therapeutic and medical device product development process, patents, and US regulatory submissions.
• Understanding of applicable regulatory requirements and guidelines, and current knowledge of trends in skin and wound management.
• Experience as a technical and subject matter expert representative on product development teams.
• Experience working with the CRO’s that will be designing, analyzing, and interpreting in vitro and in vivo skin and wound-healing studies and assays.

Qualifications

• Candidate would have a graduate degree (either an MD, P