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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

Roles and Responsibilities

• Provide expert advice on management of a platform phase 2 clinical trial investigating 3 therapeutics for the treatment of acute respiratory distress syndrome
• Review documents from the CRO and other key subcontractors for adherence to industry standards, feasibility, and quality
• Provide expert advice to the program lead in managing the clinical trial including but not limited to assessing the seriousness of issues that arise, key negotiation parameters with the CRO for completing the study within schedule and budget, determining which subject matter experts should be included in document review, and explaining key activities as they occur.
• Serve as an expert on technical evaluation panels of proposals and abstracts for therapeutics targeting influenza, COVID-19, emerging infectious diseases, critical care medicine, and other topics.
• Serve as a subject matter expert on project coordination teams by providing advice to the project lead on overall product development, clinical development, and nonclinical assay development.
• Mentor more junior members of the therapeutics team in all aspects of product development and portfolio management.
• Provide expert advice on portfolio structure and portfolio management of an advanced development therapeutics portfolio.

• Application of doctoral degree(s) in medicine or pharmacy (PharmD) or PhD with commensurate experience(s).
• Candidate will have at least 10 years of senior (executive) management experience in the pharmaceutical industry. It is preferred that the candidate have both large pharmaceutical industry experience as well as small biotech experience where their role included hands on management of clinical trials and contractors (CROs) conducting the clinical trial. The best candidates will have experience in managing phase 2 & 3 clinical trials assessing therapeutics in critical care medicine.
• Travel - as needed up to 25%

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.