BARDA Clinical Sciences and Medical Product Development for Burns & Trauma Care Subject Matter Expert

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.

Clinical Sciences and Medical Product Development for Burns & Trauma Care Subject Matter Expert

• Provide subject matter expertise in burn wound care, imaging, tissue engineering/regenerative medicine, and preclinical models of disease for testing therapeutic products, in particular burn and wound healing models, inhalation injuries, and blast trauma.
• Coordinates assigned research studies both clinical and non-clinical throughout the regulatory process from initial Institutional Review Board application until protocol closure and maintains the research database.
• Provide consistent oversight of the various assigned activities to ensure competent and standardized practices and assist to coordinate strategies to enhance inter-departmental communication and collaboration.
• Identify and facilitate research projects and completion through manuscript submission to meet Level 1 Trauma and Burn Research requirements.
• Must effectively investigate potential areas for clinical and/or trauma related systems research opportunities.
• Must have clear understanding of the research process acquired through both practical and academic experience.
• Interface with program managers, scientists, industry to obtain approval before study initiation and updating and managing databases/reports.
• Strong knowledge of the Statistical Package for the Social Sciences (SPSS).
• Analyze qualitative and quantitative data sets, including making critical observations and identifying patterns of the analyses.
• Able to effectively read and analytically interpret literature reviews of past and present research studies directly related to the subject matter.

Qualifications

• Doctoral degree in relevant fields such as clinical sciences, biochemistry, life or biomedical sciences, or biomedical engineering.
• 15+ years of clinical practice, surgical and/or pharmaceutical industrial experience, and extensive training in the relevant field.
• The successful candidate will be a SME in t