BARDA Surgical Trauma & Critical Care Supporting Clinical Sciences and Medical Product Development Subject Matter Expert

Company Description

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.  USAMMDA is the largest Department of Defense's (DoD) medical materiel development activity designed to protect and preserve the lives of Warfighters.  USAMMDA develops, modernizes, procures, and fields new drugs, vaccines, medical devices and support equipment that enhances readiness, ensuring the provision of the highest quality medical care to the DoD and maximizing survival of medical casualties on the battlefield.

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.

Surgical Trauma & Critical Care Supporting Clinical Sciences and Medical Product Development Subject Matter Expert Specific Responsibilities.

Provide subject matter expertise in the field of Clinical sciences and medical product development, with preference to work in products relevant to one or more fields such head, neck, chest, abdominal and extremity trauma, critical care, hemorrhage and TBI via their work on aspects like imaging or biologics, drugs, and/or combination products.

Qualifications

• Candidate would have a medical degree (MD/DO) and completed postgraduate training in Surgery, Trauma and Critical Care.
• Fifteen plus (15+) years of clinical practice, surgical and/or pharmaceutical industrial experience, and extensive training in the relevant field.
• Experience contributing to management of program /projects on interdisciplinary teams including implementation and reporting of preclinical studies and analytical characterization activities.
• Broad-based knowledge of biologics, therapeutic, and medical device product development process, intellectual property, and US regulatory approval process is desired.
• Understanding of trends in surgical trauma and critical care.
• Published, peer review scientific or medical articles is preferred to demonstrate your subject matter expertise.

Additional Information

All your information will be kept confidential according to EEO guidelines.