Full-Time BARDA Senior Surgical Trauma SME
BryceTech is hiring a remote Full-Time BARDA Senior Surgical Trauma SME. The career level for this job opening is Expert and is accepting Washington, DC based applicants remotely. Read complete job description before applying.
BryceTech
Job Title
Posted
Career Level
Career Level
Locations Accepted
Share
Job Details
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.
General SME Responsibilities:Support BARDA Program Office(s) as a subject matter expert. Candidates with experience in medicinal chemistry; preclinical development; advanced clinical development; analytical product testing; quality control; clinical and/or regulatory policy; manufacturing are desired.
Provide guidance and recommendations on key issues. Serve as advisor on Technical Evaluation Panels (TEPs).
Participate as subject matter experts on Program Coordination Teams (PCTs). Provide expert assessments, recommendations, and guidance.
Provide subject matter expertise and advisory support to federal staff for development of cost estimates.
Review and comment on study protocols, study reports, regulatory documents, presentations, proposals.
Develop work products (expert summary reports, expert opinion assessment reports, etc.) related to BARDA’s mission.
Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work.
Experience distilling complex information into informative summaries, including risk/benefit analyses and balanced recommendations.
Participate in strategic discussions, working with USG, in building new program areas.
Provide recommendations for project development level portfolio management and oversight.
Provide recommendations or advise on development, 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 health economic perspective to support BARDA input in ASPR planning efforts for incident response.
Provide SME support in publications and management of information on websites.
Must have a medical degree and completed postgraduate training in Surgery, Trauma and Critical Care. Fifteen plus (15+) years of clinical practice.
Experience contributing to management of program /projects on interdisciplinary teams.
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. Ability to objectively review data, documents and provide a succinct summary is required.