Director, Translational Immunology

$165,000 - $200,000/Yr

Sabin Vaccine Institute - Washington, DC

Full-time - Senior

Remote - Washington, DC

About the position

The Director of Translational Immunology plays a crucial role in advancing Sabin's vaccine pipeline by leading research and development efforts in human and nonhuman primate (NHP) immunology. This position involves overseeing the development, validation, and deployment of immune assays for clinical trials, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to integrate immunology strategies into the overall vaccine portfolio. The director will also engage with external partners and stakeholders to support vaccine licensure pathways.

Responsibilities

• Provide strong technical leadership and activity management to CROs and R&D colleagues.
• Evaluate assay development and sample testing vendors for suitability.
• Develop and implement assays for clinical and nonclinical vaccine study applications.
• Implement assays that measure antigen-specific cellular and humoral immune responses.
• Design analytical assay qualification and validation protocols.
• Author/present technical responses to assay-specific questions from regulatory authorities.
• Author immunogenicity sections of clinical protocols.
• Collaborate with clinical and statistical SMEs to draft and revise data transfer agreements and study reports.
• Ensure seamless transfer of immunological samples between clinical sites and vendors.
• Maintain internal operational documents under GxPs.
• Work with clinical team members to ensure GCP-compliant data analyses.
• Assist in comparative analyses of immune biomarker data between NHP and human vaccinees.
• Collaboratively design/implement an immune correlate of protection testing strategy for NHPs.
• Devise and maintain best practices for assay compliance in NHP studies.
• Assist in assay development and qualification activities for animal toxicity studies.
• Participate in the review of study reports, SOPs, SAPs, and publications of NHP study outcomes.
• Work closely with the VP of Translational R&D to design NHP and other animal studies.
• Facilitate cross-functional planning of assay activities.
• Work with project management to operationalize experimental and assay goals.
• Participate in meetings with consultants, partners, and funders.

Requirements

• Minimum master's degree in immunology, biochemistry, molecular/cellular biology, virology, or related discipline.
• Minimum of 12 years' biopharmaceutical product development experience with hands-on R&D experience in developing immunological assays.
• Track record of developing and deploying cellular and humoral immune assays such as ELISA and ELISpot.
• Experience conducting ex-vivo/in-vitro immune analyses on cells/tissues/blood from animals and/or human subjects.
• Analytical qualification/validation of immunological assays per ICH standards.
• Publishing immunological assays data in peer-reviewed journals.
• In-depth understanding of US regulations and current Good Laboratory Practices (GLPs).
• Hands-on experience conducting or managing immune sample testing for phase 2 and phase 3 FDA-regulated human clinical trials.

Nice-to-haves

• PhD training with robust first-hand immunology and multi-year R&D immersion.
• Grants/contracts management experience.
• Experience with FDA's Animal Rule and viral vectored vaccines.
• First-hand experience with Flow Cytometry and Systems serology.

Benefits

• Medical, Dental, Vision insurance
• Flexible Spending Accounts
• Employer paid Life and Disability insurance
• 11 paid holidays with a winter break
• Employer match on 401(k)