Director, Translational Immunology

Reports to: Vice President, Translational Research & Development (R&D)

Location: Remote Work

Position Summary: 

The Director of Translational Immunology reports to the Vice President, Translational R&D and will contribute to Sabin’s vaccine pipeline by leading human and NHP immunology R&D including nonclinical and clinical immune assays in our emerging vaccine development programs.  As a vital member of the R&D team the individual will recommend and implement experimental immunology strategies and oversee immune assay deployment within the overall vaccine portfolio. The individual will direct immune assays activities while cross functionally integrating the assays program with other functional area workstreams. The development, validation, and deployment of immunology experiments and immunogenicity assays for Phase 2-3 clinical trials and concurrent nonhuman primate studies are essential job components that feed into Sabin’s vaccine licensure pathway. 

Responsibilities:

Provide strong technical leadership and activity management to CROs and R&D colleagues to achieve the following:

Assay Development and Validation

• Evaluate assay development (AD) and sample testing vendors for suitability to conduct clinical phase-appropriate AD and testing activities
• Develop and implement assays for clinical and nonclinical vaccine study applications, including human Phase 2 and Phase 3 trials and NHP studies
• Implement assays that measure antigen-specific cellular and humoral immune responses and deploy these to better understand the mechanism of action of Sabin’s vaccines. Apply this understanding to reinforce Sabin’s regulatory approach to licensure
• Design analytical assay qualification and validation protocols and work closely with vendors to guarantee their accurate execution. Manage related assay tech transfers and review validation reports.
• Author/present technical responses to assays-specific questions and directives from regulatory authorities and stakeholders 

Clinical Assays 

• Author immunogenicity sections of Clinical protocols including primary, secondary and exploratory immunological endpoints
• In collaboration with clinical and statistical SMEs, draft and revise data transfer agreements, statistical analysis protocols (SAPs), SOPs and study reports
• Collaborate with assays vendors and clinical CROs to ensure the seamless transfer of immunological samples (blood, cells, serum/plasma) between clinical sites and vendors located on different continents
• Work with clinical testing vendors to ensure GLP-compliant assay execution and documentation
• Maintain internal operational documents under GxPs, adhering to best practices concordant with Phase 3 and commercial level of vaccine regulatory compliance.
• Work with clinical team members to ensure GCP-compliant data analyses, adherence to blinding protocols, and assays data stewardship. Participation in the presentation of statistical endpoint data and contribute to clinical study report authoring and review.

Nonclinical Assays 

• Assist in the comparative analyses of immune biomarker data between NHP and human vaccinees. Work with statisticians and nonclinical/clinical leads to ensure satisfactory immunological relevance of biomarkers/correlates of protection and their use in immunobridging strategies
• Collaboratively design/implement an immune correlate of protection testing strategy for NHPs that supports the animal rule-based approach to vaccine licensure 
• Devise, maintain and guide the implementation of best practices such establishing/certifying the appropriate compliancy level for a matrix of assays used in NHP studies
• Assist in assay development and qualification activities for animal toxicity studies including reproductive toxicology/DART
• Participate in the review of study reports, SOPs, SAPs, and publications of NHP study outcomes. 

Immunology Studies

• Work closely with the VP of Translational R&D and the Director of Preclinical studies to design NHP and other animal studies to efficiently address prevailing immunological questions needed for animal rule-based licensure strategies:     Design and execute experiments that lay groundwork for NHP to human immunobridging; Further characterize immune correlates of protection; Apply emerging technologies to answer scientific and regulatory questions around animal datasets; Better understand vaccine mechanism of action; Assess the relevance and rigor of current experimental approaches and assay methods; improve immunogenicity evaluation strategies 

Other Cross-functional

• Facilitate cross-functional planning of assays activities to align on schedules, dependencies, and funding to support phase 2 and 3 trial completion and licensure.
• Work with project management to operationalize experimental and assays goals and associated timelines, budgets, and risk mitigation strategies.
• Participate in meetings with consultants, partners and funders, including biweekly meetings with the Biomedical Advanced Research and Development Authority (BARDA); prepare and present assays-related meeting materials
• Serve as a subject matter expert for immunology-related matters and present with authority in immune assays representation during discussions with funders and global health stakeholders (e.g., WHO, Gavi, Coalition for Epidemic Preparedness Innovations (CEPI), and related)
• Participate in the preparation of grant applications, contracts and other fundraising efforts

• Minimum master’s degree in immunology (preferred), biochemistry, molecular/cellular biology, virology, or related discipline.
• Minimum of 12 years’ biopharmaceutical product development, with hands on R&D experience developing immunological assays.
• Track record of developing and deploying cellular and humoral immune assays including the following: ELISA, Pseudovirus-based neutralization assays, ELISpot, Intracellular Cytokine staining
• Experience conducting ex-vivo/in-vitro immune analyses on cells/tissues/blood harvested from animals and/or from human subjects
• Analytical qualification/validation of immunological assays per ICH standards
• Publishing immunological assays data in peer-reviewed journals

Other

• In-depth understanding of US regulations and a comprehensive working knowledge of current Good Laboratory Practices (GLPs) and regulatory guidance related to Phase 2 and Phase 3 product development, sample handling and testing
• Hands on experience conducting or managing immune sample testing for phase 2 and phase 3 FDA-regulated human clinical trials
• Authoring assays sections for INDs, NDAs, and -ex US equivalents
• Experience working in project teams with clinical and nonclinical CROs
• Enthusiasm for problem solving, discovery, and knowledge enrichment
• Comprehensive grasp of the inter-disciplinary nature of vaccine development, demonstrated with successful vaccine development through Phase 3 trials
• Ability to manage complex tasks, prioritize competing objectives and work well under pressure, maintaining clear purpose and attention to detail
• Exemplary verbal and written communication and presentation skills; ability to distill technical information to digestible concepts for partners of varied technical backgrounds
• Team player with time-proven interpersonal skills, consistently showing respect and appreciation of co-workers and colleagues
• Ability to travel frequently domestically and internationally with notice

Preferred experiences

• PhD training with robust first-hand immunology and multi-year R&D immersion
• Grants/contracts management
• First-hand experience with FDA’s Animal Rule, Filovirus biology, NHP viral challenge models, Viral vectored vaccines, Flow Cytometry, Systems serology and other methods of evaluating Fc-dependent immune functions, Luminex or related multiplexed cytokine/chemokine analyses, Modern analytical methods and instrumentation

Sabin Prerequisites for hire

• Subject to a criminal background investigation
• Request for three professional references
• Verification of education/degrees

Attributes Important to Sabin:

• Diversity, Equity and Inclusion
• Problem-Solving and Critical Thinking
• Decision-Making
• Communication and Professionalism
• Initiative and Ownership
• Productivity and Quality Control
• Professional Development/Personal Learning

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws. EEO/Veterans/Disabled

Sabin offers a competitive benefits package that includes Medical, Dental, Vision and Flexible Spending Accounts. Employer paid, Life and Disability insurance along with 11 paid holidays with a winter break between Christmas and New Years. Employer match on 401(k).

 Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the starting annual salary for this position ranges from $165,000 - $200,000. The exact compensation may vary based on skills, experience, training, certifications/degree.