Subject Matter Expert
7 hours ago
Job Title: Subject Matter Expert - Infectious Diseases
Job Summary: Direct Staffing Inc is seeking a highly experienced Subject Matter Expert to join our team as an Infectious Diseases Medical Countermeasures Developer. The ideal candidate will have a strong background in biomedical research and development, with a focus on infectious diseases.
Key Responsibilities:
- Scientific and Technical Expertise: Provide scientific and technical guidance to the Contracting Officer and Technical Project Officer on the evaluation and development of medical countermeasures against infectious diseases.
- Risk Assessment and Monitoring: Assess and monitor the risks associated with clinical development of medical countermeasures against infectious diseases.
- Technical Opinion and Analysis: Render technical opinions to the PO/CO and provide expert analysis on documents generated by BARDA contractors and federal employees.
- Concept Development and Review: Develop and review concept ideas for PBS preparedness and response acquisitions.
- Site Visits and Audits: Perform site visits/audits with PO/CO (or designated representative) to contractor facilities, and/or facilities of subcontractors, to verify compliance with contract requirements.
- Contingency Planning and Risk Reduction: Inform PO/CO of any increase/decrease in risk to success of the project and generate contingency risk reduction plans.
- Contract Negotiations: Assist in contract negotiations on technical matters, as requested.
- Strategic Positioning and Technical Counsel: Use extensive technical and industry knowledge to provide insight and technical counsel concerning BARDA's strategic position within the community developing infectious disease medical countermeasures.
- Independent Activities: Independently perform activities consistent with established organizational practices, precedents, policies, and strategic objectives set forth by BARDA management.
- Critical Thinking and Human Relations: Perform analytical, interpretive, evaluative and/or constructive thinking. Where appropriate or required, develop new methods and processes. Make use of critical human relations skills to understand, select, develop, lead, motivate, and educate others both internal and external to create teaming partnerships.
Requirements:
- A board certified medical doctor, with a specialty in internal medicine or pediatrics and subspecialty training in infectious disease focused on virology.
- 15+ years of drug/device/procedure development in the field of infectious disease with an emphasis on late stage development.
- Established reputation as a subject matter expert as evidenced by peer-reviewed publications and membership in professional associations.
- Ability to communicate well with others using excellent written and verbal communication skills.
Desired Qualifications:
- Expert in development of pharmaceutical, biological, or diagnostic products, with particular expertise in clinical development.
- Successful development of a product for infectious disease through FDA approval and licensure is highly desired.
- Experience identifying and resolving developmental technical problems.
- Extensive clinical experience in the treatment of drug-resistant infections (relevant to MD candidates only).
- Excellent people skills, with a team-oriented leadership approach.
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