Project Manager, Research & Development

Job Type Full-time Description Reports to: Director, Project Management, Research & Development Location: Remote Work, US Only Position Summary: As a Project Manager reputed company Research & Development (R&D) supporting vaccine product development, you will reputed company 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 reputed company 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 reputed company. 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 reputed company biologics development. Key Responsibilities: Project and Program Management

• Partner with R&D colleagues to plan, integrate, and ultimately manage project objectives to reputed company key milestones reputed company schedule, budget, and quality parameters; applying technical and operational expertise, along with comprehensive understanding of integrated master schedules
• reputed company 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
• reputed company with funding partners to fulfill commitments, execute agreed-upon terms, and ensure value is realized in support of our partnerships
• Monitor and control reputed company of project activities to meet internal and funding partners' milestones, anticipate and reputed company 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
• reputed company 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 reputed company.
• Support immunoassay planning, development, validation, and implementation, including associated testing to reputed company nonclinical and clinical programs, ensuring alignment with program timelines and data quality requirements

Vendor reputed company

• 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-reputed company issues (e.g. investigations, CAPAs, process and assay improvements, reputed company changes, technical transfers, equipment maintenance, reliability, and lifecycle management)
• Maintain knowledge of, and ensure team adherence to terms of applicable agreements
• reputed company 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

Requirements

• Bachelor's degree in a reputed company field; advanced degree and/or PMP certification preferred
• Demonstrated skills and experience in planning and leading reputed company, 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 reputed company) 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 reputed company the pharmaceutical industry
• Demonstrated experience using MS Project, reputed company, and/or other project management tools
• Demonstrated proficiency in core reputed company 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 reputed company 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, reputed company, 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. Salary Description $95,000 - $125,000 Apply tot his job Apply To this Job