Sabin Vaccine Institute

• Support the drafting, review, and editing of contract-related documentation for U.S. Government (USG) prime contracts, including requests for subcontracting approvals and modifications to prime awards. • Coordinate with Program Management, Subject Matter Experts, and Finance teams to gather required details and documentation to support timely submission of requests to funding agencies. • Assist with ensuring compliance with applicable regulations and prime contract terms and conditions. • Contribute to the preparation and negotiation of subawards, subcontracts, and consultant agreements, ensuring alignment with prime award requirements. • Track and monitor the status of contract actions, including approvals and modifications, helping to ensure deadlines are met. • Maintain organized contract files and documentation to ensure audit readiness and internal tracking. • Provide general administrative and operational support to the GCM team as assigned.

• The Director/Senior Director, CMC Validation reports to the Vice President, Chemistry, Manufacturing, & Controls (CMC) and is a strategic, hands-on leader responsible for building and implementing a comprehensive validation program for Sabin’s vaccines. • This individual will build Sabin’s validation strategy from the ground up and implement it across the network. • Responsibilities include authoring validation policies, procedures, templates, and related documentation; overseeing validation activities at C(D)MOs; and driving the organization to Process Performance Qualification (PPQ) readiness in alignment with FDA, EMA, WHO, and ICH expectations. • The role is accountable for designing, hiring, and leading a right-sized validation organization. • This position will partner closely across CMC, with Program & Portfolio Management, Quality Assurance, C(D)MOs, and other stakeholders to ensure validation requirements are fulfilled in a smart, risk-based manner, ultimately delivering submission-ready data packages. • The Director/Senior Director, CMC Validation serves as a validation subject matter expert (SME) with demonstrated experience building and implementing validation programs for late-phase assets. • This role will also support future funding initiatives and enable technology transfers to alternate manufacturers.

• Direct analytical activities conducted by external laboratories and contract development and manufacturing organizations (CDMOs) • Provide expert technical leadership in CMC analytical sciences including development, qualification, validation, and transfer of analytical methods • Collaborate cross-functionally to ensure analytical strategies meet regulatory expectations • Lead and oversee ICH-compliant stability programs including forced degradation studies • Compile, review, and analyze analytical data in support of development programs

• Lead the full-cycle recruitment process for R&D teams across various scientific groups, including CMC, nonclinical, clinical, regulatory, quality and project management • Collaborate with hiring managers and department leaders to understand team needs and create tailored recruitment strategies to meet those needs • Source, attract, and evaluate candidates through a combination of methods, including job boards, LinkedIn, professional networks, and direct outreach • Conduct initial pre-screenings, in-depth interviews, and assessments to ensure candidates meet technical requirements and organizational cultural • Partner with Senior Director, HR and the hiring manager to refine job descriptions, interview processes, and candidate pipelines • Maintain and manage recruitment activities in the applicant tracking system (e.g., Paylocity), ensuring up-to-date and accurate tracking of candidate progress and hiring status • Build and maintain a strong talent pipeline for current and future openings • Stay current on industry trends and talent pools within the vaccine, biotech, and pharmaceutical sectors • Represent the company at job fairs, networking events, and conferences to promote the employer brand and attract top talent • Provide a positive candidate experience through effective communication and feedback throughout the hiring process • May assist with the recruitment process of non-R&D positions that support R&D (such as finance, grants & contracts), if needed • Provide backup coverage for new hire orientation, ensuring a smooth and welcoming onboarding experience when primary coverage is unavailable • Coordinate with HR team members, hiring managers, and internal stakeholders to support onboarding logistics and timely completion of pre-employment and orientation activities • Support broader talent acquisition initiatives and programs, such as process improvements, employer branding efforts, workforce planning, and recruitment metrics, as assigned

• Provide strategic leadership for statistical activities supporting late-stage vaccine development programs • Ensure statistical rigor across clinical development, translational sciences, and CMC • Provide strategic input to senior leadership on statistical implications of development strategies • Lead statistical strategy for Phase 2/3 clinical trials • Oversee statistical deliverables from CROs and external partners • Partner with clinical and translational teams to support immunobridging models • Guide statistical design and analysis of pivotal nonclinical studies • Manage relationships with external vendors, key opinion leaders, and regulatory agencies • Mentor and develop internal statisticians and other team members

• Lead cross-functional teams in the initiation, planning, and execution of activities essential to advancing candidates through development and licensure • Ensure studies are appropriately sequenced and executed to support key milestones • Drive alignment across internal teams and external partners • Combine operational expertise with planning to manage project objectives

• Provide strategic leadership and hands-on subject-matter expertise to enable end-to-end vaccine development • Lead planning, development, and delivery of high-quality CMC content and documentation • Collaborate with CMC, Quality Assurance, manufacturing/CMOs, and other cross-functional stakeholders • Author and critically review CMC sections of U.S. FDA submissions and lifecycle updates • Drive CMC regulatory support for global development and access • Coordinate responses to CMC information requests from U.S. FDA and/or other regulatory agencies • Maintain a strong global regulatory intelligence posture • Support engagement and negotiation with regulators to resolve key CMC issues

• Manage and implement public health research with internal teams and external partners • Design epidemiological and vaccine studies, including vaccine effectiveness and impact evaluations and disease surveillance projects • Analyze complex datasets and translate data into meaningful insights for policy and practice • Develop relationships with partners to implement projects and collaborate across disciplines to strengthen the use of evidence in decision-making • Provide project oversight, problem-solving, and coordination of study-related activities • Develop and revise study protocols, standard operating procedures, and data collection tools • Lead regular calls with project staff, including principal investigators • Manage communications with funders, data and safety monitoring boards, external partners • Oversee site monitoring visits to ensure study objectives are met • Conduct advanced statistical analyses; experience with R strongly preferred • Translate research findings into policy-relevant recommendations and actions • Contribute significantly to writing grant proposals and concept notes

• Provide comprehensive technical support and expertise in risk-based quality management of clinical trials • Oversee internal and external compliance with ICH E6 (R3), organizational procedures, and applicable regulatory standards • Support the Marburg Vaccine (cAd3-Marburg) and Sudan Virus Vaccine (cAd3-Sudan) development activities • Promote a quality culture within the organization • Partner with Clinical Operations, CROs, and clinical sites to provide GXP CQA oversight • Develop risk-based clinical quality sponsor oversight initiatives • Plan and conduct audits of CROs, clinical sites, and documentation, ensuring compliance with policies and regulations • Author audit reports and oversee findings until resolution, including implementation of any CAPAs through effectiveness checks • Participate in internal and external audits/inspections including other quality assurance assigned activities • Assist in development and implementation of sponsor oversight and quality systems to identify trends and noncompliance • Manage, create and review CQA SOP’s and documentation as required • Assist in development and implementation of quality systems to identify, initiate and monitor corrective and preventive actions.

• Provide strategic leadership for all aspects of Global Immunization (GI) resource development • Develop, oversee, and refine GI’s resource development strategy, ensuring alignment with GI’s goals and Sabin’s goals and mission with possible funding opportunities • Identify new opportunities, while addressing risks and threats relevant to fundraising and partnership engagement, and elevate them to the GI President and/or Executive Team • Develop targeted fundraising approaches that support current and new initiatives and strengthen Sabin’s influence in the global immunization ecosystem • Demonstrate openness to innovation and expanding Sabin’s immunization work in relation to climate resilience and HPV prevention • Lead the development and execution of annual and multi-year fundraising goals and plans, including setting growth-oriented fundraising goals and non-traditional funders • Identify, assess, and pursue multi-year, multi-million-dollar funding opportunities from funders (governments, foundations, corporations, non-governmental organizations, academia, and high-net-worth individuals) • Oversee development of funding proposals for the GI team, managing internal and external teams, partner relationships, timelines, and submission processes; work with Sabin’s finance team on proposal budget, as needed • Prepare and present progress reports for the GI President, GI team and CEO; author respective materials for the Board of Trustees meetings • Oversee, with Sabin’s grants and contracts team, post-award grant compliance and reporting standards • Identify, cultivate, engage, and guide current and prospective funders across GI’s diverse portfolio, engaging the GI President, CEO and Trustees, as needed • Champion the development of transformative partnerships • Collaborate closely with the GI team to align across sectors and multi-regional actors around shared goals, catalyzing innovation and unlocking funding opportunities • Drive the funding engagement lifecycle - solicitation, stewardship, and relationship management • Ensure quality and consistency of funders’ communications and engagement with the GI team’s strategic priorities and Sabin’s mission • Provide strategic oversight and quality control for all GI fundraising and partnership materials • Collaborate with Sabin’s Vice President, Communications, to co-create high-impact fundraising materials that align with GI objectives • Represent and promote Sabin and the GI team’s work at events or meetings • Prepare resource development presentations, executive talking points, and briefing decks for the GI President, CEO, and Trustees