Senior Surgical Trauma & Critical Care supporting Clinical Sciences and Medical Product Development SME

Overview:

LMI is seeking an Senior Surgical Trauma & Critical Care supporting Clinical Sciences and Medical Product Development SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.

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. Candidates with experience in the following areas are desired: 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.

LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.

LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!

• 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), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.

• Provide health economic perspective as needed to support for BARDA input in ASPR planning efforts for incident response for material threat incidents.
• Provide SME support in publications and management of information on websites as required

• Medical degree (MD/DO) and completed postgraduate training in Surgery, Trauma and Critical Care
• Minimum of fifteen (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
• Experience in public health service setting and exposure to both exercises and or response activities are an advantage
• Ability to objectively review data, documents (RFPs, Reports, models) and provide a succinct summary and guidance for making decisions by USG managers is required part of this role 
• Ability to obtain a public trust clearance. You must be a U.S. citizen.