Sr. Therapeutic Development SME at TUNNELL GOVERNMENT SERVICES in Bethesda, Maryland

Job Description:

Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.

Tunnell Government Services - BARDA Program

Sr. Therapeutic Development SME

A Subject Matter Expert in therapeutic development is needed to provide contracted support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. The mission of BARDA is to develop and procure medical countermeasures (MCM) that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. For more information on BARDA please visit their website at: http://www.phe.gov/about/BARDA/Pages/default.aspx

Major Duties & Responsibilities:

• Support BARDA Program Office(s) as a subject matter expert in therapeutic advanced development including clinical, regulatory policy, development feasibility and marketability of therapeutic candidates.
• Provide guidance documents and option papers on key issues related to the area(s) identified; Review contract proposal and related documents.
• Provide senior-level briefing(s) to ASPR/BARDA as required; Prepare regular reports to ASPR/BARDA management on various technical issues identified.
• Provide project development level portfolio management and oversight.
• Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.

Deliverables:
Provide subject matter expertise in all aspects of influenza and emerging infectious disease antiviral and host-targeted drug development, including but not limited to high throughput screening and hit to lead, preclinical, clinical, regulatory, and manufacturing. Deliverables would include work products related to the development and management of regulatory studies and licensure programs within current and planned BARDA therapeutic development and acquisition contracts.

Requirements:

• At least fifteen (15) years of relevant industry experience
• Application of doctoral degree(s) in medicine or pharmacy (PharmD) or PhD with commensurate experience(s).
• Experience with Phase 2 & 3 clinical trials in critical care, pulmonary, immunology and/or infectious diseases studies

Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.

Please be advised that some of our client contracts, including contracts with the federal government, require us to validate that our employees and contractors are fully vaccinated against COVID-19, subject to legal requirements. If you are selected for this role or assignment, you will be required to confirm that you are fully vaccinated or engage in an interactive dialogue with Human Resources to determine if you are eligible for a religious or medical exception, and whether making such an exception would pose an undue burden or undue risk of harm.

Apply Now