Department: Research & Development 

Reports to: Director of Translational Immunology 

Location:  Fully Remote- Remote Worker, US Only 

Term:  USG funding through Clinical Phase 2 Trials with possibility for extension pending additional funding.  This position is eligible for full benefits. 

Why Sabin

Our  mission is to make vaccines more accessible, enable innovation and  expand immunization across the globe. We seek a future free from  vaccine-preventable diseases. We are an innovative, collaborative, and  engaged team that values accountability, teamwork, partnership and  driving impact. We are vaccine champions improving lives through  immunization. Sabin staff, management and the Board of Trustees are  committed to ensuring that fairness, integrity, and opportunity remain  at the core of how we operate. 

Position Summary

The  Senior Manager of Clinical/Nonclinical Assays reports to the Director,  Translational R&D and will contribute to Sabin’s vaccine pipeline by  supporting 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 provide  laboratory method and regulatory compliance expertise to immune assay  development and deployment within the overall vaccine portfolio. 

The  individual will manage 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 support 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.  
• 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.  

Clinical Assays 

• 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.

Nonclinical Assays 

• 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

Immunology Studies

• 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
• 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. 
• 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 

• 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

Preferred experiences

• First-hand experience with:
• Filovirus biology
• NHP viral challenge models
• Viral vectored vaccines
• Flow Cytometry
• Modern analytical methods and instrumentation

Other:

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

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 $109,000 - $140,000. The exact compensation may vary based on skills, experience,  training, certifications/degree. As a grant-funded organization, Sabin  actively seeks funding for existing and new programs. 

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 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.