What are the responsibilities and job description for the Senior Clinical Operations SME position at LMI Consulting, LLC?
Senior Clinical Operations SME
Job Locations US-Remote
Job ID
2025-12355
of Openings
Category
Engineering
Overview
LMI is seeking a Senior Clinical Operations 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!
Responsibilities
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.
- Serve as an internal project manager / clinical team leader monitoring, assessing, and course-correcting contractors and vendors.
- Prepare and manage timelines, budgets, and other key deliverables.
- Develop and implement risk assessment and mitigation strategies.
- Ensure regulatory processes and guidelines are followed, including co-authoring, and reviewing regulatory submissions to the US Food and Drug Administration (FDA)
- Author, review, develop Request for Task Orders (RTORs) and evaluate Clinical Research Organization (CRO) proposals.
- Provide independent cost, resource, and timeline estimates when requested.
- Review and / or develop work products related to the development and management of clinical studies and programs within current and planned BARDA products in vaccine, therapeutic, diagnostics, and devices advanced development and acquisition contracts.
- Overall clinical operations oversight.
- Review of study specific documents, including invoices, with provision of output.
Qualifications
LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact accommodations@lmi.org
Colorado Residents : In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
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