Sabin Vaccine Institute

Manager

• 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

Senior Manager, Clinical/Nonclinical Assays

QA Engineer

• Manage and maintain controlled quality documentation, including SOPs, policies, forms, and work instructions, in compliance with applicable regulatory and industry standards.
• Participate in the implementation, administration and oversight of the document control process in Master Control, ensuring documents are reviewed, approved, released, and archived according to company procedures.
• Support the vendor qualification program, internal and external audits by ensuring documentation is accurate, accessible, and audit ready.
• Collaborate in cross-functional teams to support organizational needs.
• Ensure compliance with FDA, EMA, ICH, and other applicable regulatory requirements.

Quality Assurance Documentation Specialist

• Provide project oversight, problem-solving, and coordination of study-related activities
• Develop and revise study protocols, standard operating procedures, and data collection tools, as needed
• Lead regular calls with project staff, including principal investigators
• Manage communications with funder, data and safety monitoring board, external partners
• Oversee and conduct site monitoring visits to ensure study objectives are met; prepare site monitoring reports, including recommendations
• Develop presentations and data summaries
• Coordinate dissemination of study results in peer-reviewed publications
• Experience with complex data management, including data cleaning, verification, and quality assurance for large, multi-country datasets
• Experience with advanced statistical and mathematical modeling approaches, including geographic and spatial analysis and predictive disease modeling methods desired
• Create and maintain data monitoring scripts for study progress and quality
• Oversee the development and maintenance of study databases, with a strong preference for candidates who have experience developing databases themselves, ensuring data integrity
• Design and implement statistical analysis plans
• Conduct advanced statistical analyses; experience with R strongly preferred
• Encourage innovative approaches to data analysis and visualization to communicate results effectively
• Integrate analytical findings into reports and visualizations that inform programmatic and policy decisions
• Translate research findings into policy-relevant recommendations and actions
• Support evidence-to-policy initiatives and contribute to data-driven advocacy efforts
• Engage with key stakeholders (e.g., WHO, Gavi, ministries of health, and other global health partners) to share insights and inform decision-making
• Contribute to policy briefs, presentations, and other communication materials that highlight evidence-based recommendations
• Contribute significantly to writing grant proposals and concept notes, including literature review and study design components
• Lead annual progress and financial reporting on grant outcomes and milestones
• Support management of sub-contracting and partners budgets
• Prepare activity summaries for funder
• Other related duties, as assigned

Senior Manager, Applied Epidemiology

Clinical Operations

• Reports to: Vice President, Clinical Operations
• Oversee clinical trial execution and manage clinical data contributions to advance Sabin’s vaccine candidates towards regulatory authorization and/or licensure
• Manage clinical trial vendors and CROs to ensure Sabin’s trials comply with Good Clinical Practices (GCPs), Good Clinical Laboratory Practices (GCLPs), Good Pharmacovigilance Practices (GPVPs) and applicable international and country-specific regulations
• Actively manage clinical operations; collaborate with the CRO to develop a robust and integrated risk management program in accordance with ICH E6 (R2)
• Accountable for management of all clinical operation activities including proactive identification of work streams and dependencies, key risk indicators, resources, and milestones
• Collaboratively oversee quality audits of CROs and investigational sites
• Manage clinical trial materials logistics: investigational product labeling, shipping and storage, as well as sample collection and logistics from clinical sites
• Responsible and accountable for ensuring accurate and up-to-date study and program information within relevant tracking systems and providing regular updates; proactively identify, risk-manage, and resolve issues that arise during study and program conduct; manage escalation of study and program-related issues
• Contribute to the development of clinical trials related documentation including Investigator Brochures, trial master files, clinical study reports, protocols, and protocol amendment and patient-facing documents (e.g., informed consent forms)
• Plan, coordinate, control and continuously improve processes and systems to assure quality and compliance of clinical studies; provide input and change management for quality improvements
• Ensure proper performance of clinical data management, including proper implementation of electronic data capture for every trial, creation of eCRF/EDC Specifications and database design and build
• Working with regulatory affairs, contribute to the review of IND, EUA and BLA submissions as required to ensure data and documents meet GCP guidelines; perform quality and compliance checks of relevant clinical documents and regulatory dossiers (e.g., Investigator's Brochure, CRF, Clinical Study Reports and clinical sections in IND/EUA/BLA/MAA submission) to ensure data integrity and accuracy
• Contribute to the development of funding proposals, clinical product development plans and protocols
• Support Sabin’s work environment focused on quality and foster learning, respect, open communication, collaboration, integration, and teamwork
• Ensure compliance with internal and external policies and regulations, as applicable
• Represent Sabin and promote its mission at events and meetings
• Other duties as assigned

Senior Manager, Clinical/Nonclinical Assays

Quality Assurance Documentation Specialist

Senior Manager, Applied Epidemiology

Director, Clinical Operations