Full-Time BARDA Clinical Ops SME

BARDA Clinical Operations Subject Matter Expert

Background: The Center for the Biomedical Advanced Research and Development Authority (BARDA) provides an integrated, systematic approach to the development of vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. Together with industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans.

General SME Responsibilities:

• Support BARDA Program Office(s) in various areas, including chemical, radiological/nuclear threats, burn/blast injuries, biological threats, influenza, and emerging infectious diseases.
• Provide guidance and recommendations on research, development, manufacturing, and regulatory approval of medical countermeasures.
• Serve as advisor on Technical Evaluation Panels (TEPs).
• Participate as subject matter expert on Program Coordination Teams (PCTs).
• Provide expert assessments, recommendations, and guidance to PCT and COR.
• Provide subject matter expertise for cost estimates.
• Review study protocols, reports, regulatory documents, and proposals.
• Develop work products (e.g., expert summary reports, analysis reports, manuscript writing).
• Advise federal staff on contractor proposals and improvement suggestions.
• Participate in strategic discussions and building new program areas.
• Provide recommendations on project development, portfolio management, and Total Life Cycle Cost (TLCC) efforts.
• Participate in Market Research efforts.

Responsibilities specific to Clinical Operations:

• Serve as internal project manager/clinical team leader.
• Prepare and manage timelines, budgets, and deliverables.
• Ensure regulatory compliance.
• Author, review, and develop Request for Task Orders (RTORs).
• Review and develop work products for clinical studies.
• Provide overall clinical operations oversight.
• Review study-specific documents.

Qualifications:

• At least 5 years of clinical trial operations experience, including observational and phase 1-IV trials.
• Advanced degree in medicine, nursing, pharmacy, biotechnology, or related field.
• Experience in Clinical Research Organizations, private research organizations, pharma, academia, or government.

What is the last date for applying to the job?

Which countries are accepted for this remote job?