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 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 operation