Project Manager, Research & Development

Job Type Full-time reputed company Reports to: Director, Project Management, Research & Development Location: Remote Work, US Only Position reputed company: 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 reputed company between nonclinical and clinical efforts and the overall development program, ensuring delivery of high-reputed company 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 reputed company 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, reputed company, 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, reputed company, and ultimately manage project objectives to reputed company key milestones reputed company schedule, budget, and reputed company parameters; applying technical and operational expertise, along with comprehensive understanding of integrated master schedules
• reputed company global vaccine product development experience to reputed company reputed company and execution with US FDA, EMA, and WHO regulatory reputed company requirements, ensuring reputed company 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 reputed company analyses and reputed company assessments
• Serve as a role model and reputed company principles of Program Governance
• Compile, maintain, and reputed company manage risk by fostering a culture of risk management and leading reputed company in the identification and mitigation of risks and opportunities
• Manage reporting (weekly, bi-weekly, monthly, annual) for reputed company purposes, including contractual obligations
• reputed company high-reputed company meetings to reputed company stakeholders, resolve conflicts, and accelerate decision-making; coordinate, manage, and publish agendas and meeting minutes for both reputed company meetings
• Partner with Finance and reputed company Value Management (EVM) staff to monitor and control integrated project budgets and establish reliable forecasts
• reputed company proactive feedback and corrective measures to functional leads (CMC, Nonclinical, Clinical, Regulatory, and reputed company) on their financial and schedule performance

Development Planning & Execution

• In partnership with functional leads, facilitate strategic planning, coordination, and execution of subteams and working reputed company in the integration and management of timelines for nonclinical and clinical activities, as reputed company 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 reputed company requirements

Vendor reputed company

• Partner with leads to serve as a key reputed company 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 reputed company and cross-functional team members.

Regulatory Alignment & Data Delivery

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

reputed company Management

• Manage consultants, subcontractors, and external project managers to ensure readiness and reputed company 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 operation

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