Clinical Project Manager / Senior Clinical Project Manager (R&D)

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 Clinical Project Manager within Research & Development (R&D) supporting vaccine development, you will lead project teams enabling the initiation, planning, and execution of Clinical activities across all phases of development (Phase 1 through Phase 3, as well as post-licensure). You will serve as a link between Clinical efforts and the overall program, ensuring delivery of high-quality Clinical data aligned with development program timelines, budgets, and milestones.

First-hand vaccine/biologics product development Project Management experience inclusive of strategy, planning and execution, as well as advanced knowledge of resource, scope, schedule, cost, quality, and risk management are required for this position.

Responsibilities:

Project and Program Management fundamentals:  

• Partner closely with Program leadership for the establishment of strategies, plans, schedules, and budgets, and subsequently ensure delivery upon these pillars
• Lead high-impact meetings to align stakeholders, drive progress-to-plan, resolve conflicts, and accelerate decision-making; coordinate, manage, and publish agendas and meeting minutes for both internal and external meetings
• Develop and manage detailed project budgets and timelines. Partner with Finance and Earned Value Management team to monitor forecast vs. actuals, track accruals, and support variance analysis. Provide proactive feedback and corrective measures to leads on their financial and schedule performance. Manage cross-functional resource coordination to avoid timeline disruptions.
• 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 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
• Support the planning and delivery of organizational objectives and goals to ensure successful R&D-wide evolution in support of our mission and advancement of our vaccine product development programs
• Develop and refine project management tools which foster alignment, communication, and performance

Clinical Development Planning & Execution:  

• Partner with Clinical Development and Operations leads to develop Clinical program timelines and operational plans.
• Facilitate the development of clinical strategies and trial designs by conducting meetings which enable alignment and decision making.
• Ensure strategy is linked with execution to deliver study milestones per schedule. 

Clinical Vendor Oversight:

• Monitor and control vendor performance aligned to contract and timelines, support issue resolution, and contribute to risk mitigation planning in collaboration with Clinical Operations.

Quality, Regulatory, and GCP Compliance Monitoring:  

• Support audit readiness and coordinate responses to audit findings and regulatory inspections in collaboration with Clinical Operations and QA.

Data Management, Sample Management, and Reporting:  

• Track progress of Clinical data collection, query resolution, and interim/final data reviews and integrate into overall program schedule. Escalate risks and opportunities to ensure timely resolution, resulting in schedule adherence.
• Serve as the link between Clinical and Translational R&D teams and associated vendors to ensure sample plans, logistics, timelines, and testing execution are coordinated and delivered per schedule.
• Ensure coordination with Biostatistics, Data Management, and Medical team to enable timely delivery of Clinical study reports (CSRs), regulatory documentation and eTMF transfers.

Global Study Coordination & Stakeholder Engagement:

• In partnership with Clinical Operations, facilitate communication between global study sites, internal teams, and external investigators.
• Support data harmonization and cross-regional alignment.

Post-Trial and Lifecycle Support: 

• Coordinate planning for post-trial obligations including follow-up visits, long-term safety monitoring, and regulatory filing support.
• Coordinate planning for post-marketing commitments and real-world evidence generation, where applicable.
• Provide a Pharmacovigilance team with PM expertise and coordination.

• Bachelor’s degree in a scientific field; advanced degree and/or PMP certification preferred
• 7+ years of relevant experience in project and program management; demonstrated skills and experience in planning and leading complex, multi-year, integrated vaccine/biologic product development programs with multiple funding partners and vendors
• Experience implementing monitoring and evaluation tools 
• Experience with Governance practices within pharmaceutical industry
• Experience with Earned Value Management and project controls of vaccine/biologic project and program schedules and budgets
• Advanced experience using MS Project, Smartsheet, and/or other project management tools
• Advanced experience using 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 10-20% domestically and internationally 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 starting annual salary for this position ranges from $108,000 - $164,000. 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.