Senior Manager, Clinical/Nonclinical Assays

Role Overview

• Provide strong technical support and activity management to CROs and R&D colleagues
• 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.
• 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 technical responses to assays-specific questions and directives from regulatory authorities and stakeholders.
• In collaboration with clinical and statistical SMEs, review, draft, and revise assay related sections of 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 stewardship over clinical immunology samples (e.g., serum and PBMCs) and assay data.
• Collaboratively support the design/ and implementation 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
• Participate in the drafting and review of study reports, SOPs, SAPs, and publications of NHP study outcomes
• Work closely with the Translational R&D leadership to provide assay-related expertise for NHP and other animal studies to efficiently develop and characterize mechanistic immunological assays needed for animal rule-based licensure strategies:
• Provide assay support for the design and execution of experiments that lay groundwork for NHP to human immunobridging
• Further characterize immune correlates of protection
• Assess the relevance and rigor of current experimental approaches and assay methods; improve immunogenicity evaluation strategies
• 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.
• Facilitate data collection, quality control, organization, and analysis to strengthen the data infrastructure of the Translational R&D team
• 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 immune assays for communications 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

Requirements

• Minimum Bachelor’s degree in immunology (preferred), biochemistry, molecular/cellular biology, virology, or related discipline.
• Minimum of 10 years’ analytical assay development, with hands on experience with immunological assay development, tech transfer, verification, qualification, and validation
• 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 and/or direct contributions to licensed vaccines or other biologicals.
• 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
• Experience working in project teams with or within 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

Tech Stack

• Google Cloud Platform

Benefits

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