Reports to: Director, Project Management, Research & Development

Location: Remote Work, US Only

 

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: 

As a Project Manager within Research & Development (R&D) supporting vaccine product development, you will lead cross-functional teams in the initiation, planning, and execution of activities essential to advancing candidates through development and licensure, particularly under the FDA Animal Rule (21 CFR 601.90). You will serve as a key link between nonclinical and clinical efforts and the overall development program, ensuring delivery of high-quality data aligned with program timelines, budgets, and milestones. You will also ensure studies are appropriately sequenced and executed to support key milestones, decision points, and regulatory interactions.

The Project Manager will drive alignment across internal teams and external partners, including CROs, collaborators, and government stakeholders, ensuring clear expectations, effective communication, and on-time, on-budget delivery of activities.

The incumbent will have first-hand experience in vaccine/biologics product development, including planning and execution of development strategies and integration with regulatory pathways. Advanced knowledge of project management principles, including scope, schedule, cost, resource, quality, and risk management, is required, along with a strong understanding of R&D operations supporting complex biologics development.

Key Responsibilities:

Project and Program Management 

• Partner with R&D colleagues to plan, integrate, and ultimately manage project objectives to achieve key milestones within schedule, budget, and quality parameters; applying technical and operational expertise, along with comprehensive understanding of integrated master schedules
• Leverage global vaccine product development experience to align strategy and execution with US FDA, EMA, and WHO regulatory pathway requirements, ensuring timely submissions and inspection readiness
• Interface with funding partners to fulfill commitments, execute agreed-upon terms, and ensure value is realized in support of our partnerships
• Monitor and control progress of project activities to meet internal and funding partners’ milestones, anticipate and highlight potential variances and plausible solutions, and support team in critical path analyses and impact assessments
• Serve as a role model and uphold principles of Program Governance
• Compile, maintain, and actively manage risk by fostering a culture of risk management and leading the team in the identification and mitigation of risks and opportunities
• Manage reporting (weekly, bi-weekly, monthly, annual) for internal and external purposes, including contractual obligations
• Lead high-impact meetings to align stakeholders, resolve conflicts, and accelerate decision-making; coordinate, manage, and publish agendas and meeting minutes for both internal and external meetings 
• Partner with Finance and Earned Value Management (EVM) staff to monitor and control integrated project budgets and establish reliable forecasts 
• Provide proactive feedback and corrective measures to functional leads (CMC, Nonclinical, Clinical, Regulatory, and Quality) on their financial and schedule performance 

Development Planning & Execution

• In partnership with functional leads, facilitate strategic planning, coordination, and execution of subteams and working groups in the integration and management of timelines for nonclinical and clinical activities, as well as FDA and EMA engagements. Ensure alignment with overall program development plans and regulatory pathways.
• Support immunoassay planning, development, validation, and implementation, including associated testing to enable nonclinical and clinical programs, ensuring alignment with program timelines and data quality requirements

Vendor Oversight

• Partner with leads to serve as a key liaison between Sabin, external vendors, and funding partners to coordinate execution of activities, including model development, immunoassay development and testing, and study conduct at BSL-3 and BSL-4 facilities. Support inspection readiness and response planning in collaboration with Quality and cross-functional team members.

Regulatory Alignment & Data Delivery

• Track preparation and submission of regulatory filings (e.g., IND, BLA). Drive the planning, execution, and timely delivery of required studies to support regulatory submissions.

Alliance Management

• Manage  consultants, subcontractors, and external project managers to ensure readiness  and timely execution of deliverables to schedule and budget
• Support  external  vendors  with project-related issues (e.g. investigations, CAPAs, process and assay improvements, source changes, technical transfers, equipment maintenance, reliability,      and lifecycle management)
• Maintain  knowledge of, and ensure team adherence to terms of applicable agreements
• Lead  periodic business and operations review meetings 
• Support  sourcing efforts for new activities, including participation in due diligence, assessing requirements, and risk mitigation strategies

Operations Management

• Support the planning and delivery of organizational goals to ensure successful R&D-wide evolution in support of our mission and advancement of our vaccine product development programs
• Support  R&D-wide efforts, including but not limited to system, process, tool,  and infrastructure building

• Bachelor’s  degree in a related field; advanced degree and/or PMP certification  preferred
• Demonstrated  skills and experience in planning and leading complex, multi-year,  integrated vaccine/biologic product development programs and associated budgets,  with multiple funding partners and vendors
• Experience  with Earned Value Management and project controls of vaccine/biologic  project and program schedules and budgets is highly desirable
• Experience leading efforts supported by public and philanthropic health funders  (e.g., U.S. government agencies such as HHS/BARDA and global organizations  like CEPI or Gates Foundation) is highly desirable
• 7+ years  of relevant experience in project and program management
• Proven  experience implementing monitoring and evaluation tools 
• Demonstrated  experience with Governance practices within the pharmaceutical industry
• Demonstrated  experience using MS Project, Smartsheet, and/or other project management tools
• Demonstrated proficiency in core  Microsoft 365 applications, including MS Teams and SharePoint
• Ability to work across the organization and build strong relationships with  colleagues, managing their expectations
• Strong communication and interpersonal skills; ability to be  flexible and optimistic
• Strong attention to detail, ability to manage complex tasks, highly organized,  dependable, and able to prioritize competing demands to meet deadlines
• Ability to process information quickly and listen carefully to feedback and comments from staff and adapt plans/actions accordingly
• Commitment  to furthering Sabin’s mission 
• Ability to travel approximately 5-10% domestically with notice

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 annual salary for this position ranges from $95,000 - $125,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.

Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short-term and long-term disability options. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.

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.