Subject Matter Expert - Infectious Diseases
- Full-time
- Pharmaceutical / Biotech
- Washington, D.C.
- Exp 10-15 years
- Relo
- Bonus
Job Description: Subject Matter Expert (SME) for Development and Evaluation of Infectious Disease Countermeasures and Diagnostic Devices.
POSITION OVERVIEW: The Biomedical Advanced Research and Development Authority (BARDA) is responsible for the advanced development and procurement of medical countermeasures under Project BioShield. A large proportion of the countermeasures of interest are directed against infectious agents. The successful candidate will provide strategic and technical direction to BARDA's efforts to develop innovative treatments, diagnostic devices, and preventive measures that address threats posed by infectious disease. The SME is expected to serve as a reliable resource of technical counsel to BARDA and to companies that receive BARDA funding. The candidate will provide an interface between the government, operational staff, and BARDA's industry partners. To be successful, the candidate must clearly communicate thoughts and ideas to senior government managers and other stakeholders. An extraordinary degree of ingenuity, creativity, and resourcefulness in the development, application, evaluation, and development of advanced technologies, scientific principles, theories, and concepts is expected to ensure the appropriate development of medical countermeasures against infectious agents. The candidate will be responsible for technical problem solving, data analyses, documentation of procedures and results, performing audits, and writing progress and final reports about medical countermeasures that address infectious diseases. BARDA is organized based on a matrix concept, and each member may be required to contribute his expertise to a number of different therapeutic areas.
MAJOR RESPONSIBILITIES:
Serve as scientific and technical representative to the Contracting Officer (CO) and Technical Project Officer (PO) concerning the evaluation and development of medical countermeasures against infectious diseases.Assess and monitor the risks associated with clinical development of medical countermeasures against infectious diseases.Render technical opinions to the PO/CO.Provide concept ideas for PBS preparedness and response acquisitions.Review for technical correctness and give expert analysis regarding documents generated by BARDA contractors and federal employees.Actively participate in meetings with federal and contractor employees to obtain and evaluate project status and progress against contract milestones.Perform site visits/audits with PO/CO (or designated representative) to contractor facilities, and/or facilities of subcontractors, to verify compliance with contract requirements. Site visits/audits will include international travel.Inform PO/CO of any increase/decrease in risk to success of the project and generate contingency risk reduction plans.Assist in contract negotiations on technical matters, as requested.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.Independently perform activities consistent with established organizational practices, precedents, policies, and strategic objectives set forth by BARDA management.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.
All your information will be kept confidential according to EEO guidelines.
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