Immunology SME

Tunnell Government Services•Bethesda, MD

About The Position

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 Immunology SME A Subject Matter Expert in viral immunology with primary research focus on influenza virus-host interactions and human influenza immunity 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, evaluate, and procure medical countermeasures (MCMs) 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: https://www.medicalcountermeasures.gov/

Requirements

PhD., M.D., or equivalent in immunology, virology, microbiology, or related field with specialization in viral immunology. Postdoctoral training in influenza immunology strongly preferred.
10-15 years as principal investigator or senior scientist in influenza immunology research is preferred, evidenced by first or senior author publications on influenza immune responses, pathogenesis, or vaccine immunology. Experience with other respiratory viruses (RSV, SARS-CoV-2, human metapneumovirus, parainfluenza) is a plus.
Hands-on vaccine/therapeutic product development experience and direct involvement in clinical studies (immunology lead role) highly desirable.
Working knowledge of regulatory frameworks (FDA CBER, EMA CHMP), including immunogenicity data expectations, correlates of protection, regulatory submission requirements, and accelerated approval pathways, highly desirable.
Demonstrated ability to translate immunological concepts into strategic recommendations for product development and public health decision-making.
Track record of scientific leadership through invited presentations, advisory board service, grant review panels, and recognition as a thought leader in influenza immunology.
Must be a United States Citizen or a Full Green Card holder.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

Responsibilities

Provide scientific expertise in influenza vaccine development and evaluation, with deep understanding of zoonotic influenza, influenza-specific immunity including antigenic drift/shift, cross-reactive antibody responses, heterosubtypic immunity, neuraminidase and non-HA antibodies, mucosal immunity, and T cell responses to conserved epitopes.
Apply expertise in host-pathogen interactions, immune evasion mechanisms, and immunopathology of severe influenza to inform development strategies for vaccines and therapeutics.
Support clinical and nonclinical study design emphasizing safety, immunogenicity, and influenza-relevant endpoints.
Contribute to regulatory strategy and documentation for vaccine products, collaborating with multidisciplinary teams on pandemic preparedness.
Provide expert advice on the development and implementation of innovative immune assays and research strategies to identify novel correlates of protection.
Conduct expert scientific evaluation of influenza vaccines from BARDA partners, assessing immunogen design, adjuvant strategies, mechanisms of protection, scientific rationale for novel approaches, likelihood of achieving broadly protective immunity, adequacy of proposed immunological assays and correlates of protection, and translational potential from preclinical models to human efficacy.
Design and critique clinical trial protocols with appropriate immunological endpoints (HAI, microneutralization, ADCC, T cell assays, mucosal immunity measures), age-appropriate cohorts, and seasonal versus pandemic preparedness strategies.
Maintain current expertise in development challenges including immune imprinting and original antigenic sin, broadly neutralizing antibodies, immunosenescence in elderly populations, manufacturing scalability for pandemic response, and emerging approaches to broadly protective vaccines. Proactively identify and recommend evidence-based risk mitigation strategies.
Monitor competitive landscape of influenza vaccine candidates in clinical and preclinical development, including novel platforms, and provide strategic intelligence on scientific differentiation and portfolio gaps.
Demonstrate continuous engagement with the influenza research community through literature review and awareness of emerging data on influenza virus evolution, zoonotic threats, and pandemic preparedness.
Support BARDA project management by providing subject matter expertise for program reviews, milestone assessments, and go/no-go decision points.
Contribute to strategic planning and implementation of new initiatives, including identification of research gaps, innovative vaccine concepts worthy of investment, and alignment with national and global influenza surveillance and preparedness priorities.