Sr. Clinical Project Manager, New Product Introduction (NPI)

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Position Title: Senior Clinical Project Manager, New Product Introduction

Location: Assembly Drive, Rockford

Department:  Project Management

Shift:  First Shift

Reporting To: Director, Project Management

Responsible For (Staff): Yes

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Project Execution and Delivery

• Own end-to-end project-level execution of assigned Advanced Drug Delivery (ADD) programs from award through Clinical program launch, managing the integrated project timeline including milestones, dependencies, and deliverables.

• Maintain and manage project plans, action trackers, and RAID logs in Smartsheet. Track progress against milestones and escalate schedule, cost, or scope risks to the Sr. Clinical Program Manager early.

• Prepare and deliver weekly project status updates for internal governance and leadership reporting, ensuring documentation, templates, and systems (Smartsheet, JDE) remain accurate and current.

• Ensure all project activities follow the ADD Playbook and standard ways of working established.

• Ensure all activities are performed in accordance with cGMP, FDA 21 CFR 211, applicable regulatory standards, and PCI SOPs and EHS requirements.

Cross-Functional Coordination

• Drive cross-functional coordination across Engineering, Quality Assurance, Quality Engineering, Operations, Procurement, and Validation to ensure project deliverables stay on track.

• Lead internal weekly project team meetings and ensure clear accountability for action items across all functional areas.

• Align Engineering, QA, Operations, and Validation on technical requirements, material readiness, and validation plans. Ensure procurement timelines and material availability align with project milestones.

• Accountable for executing a comprehensive and well-documented transition of the project to the Clinical Project Management team, ensuring continuity and readiness following completion of ADD launch activities.

Customer and Stakeholder Communication

• Serve as the primary day-to-day operational contact for assigned clients during ADD project launch, escalating strategic or relationship-level issues to leadership team.

• Provide internal and external project status reporting including schedule adherence, risk and issue summaries, and budget status as required.

Operational Readiness and Stage-Gate Management

• Lead projects across the full ADD lifecycle (Kickoff through Clinical Launch), ensuring readiness alignment, and completion of deliverables at defined key milestones.

• Coordinate activities required for technology transfer, engineering runs, process line trials (PLT), process qualification (PQ/PPQ), and launch readiness.

• Ensure production readiness prior to key manufacturing phases. Confirm batch records, specifications, and quality approvals are in place before validation runs.

• Track material readiness including components, tooling, and materials to ensure arrival in time for engineering and validation runs. Coordinate with Procurement to resolve shortages or lead time issues.

• Ensure program timelines account for regulatory submissions, approvals, and inspection readiness

Financial and Scope Oversight

• Monitor project scope against contracted work, identifying potential changes and initiating Change Orders as needed to ensure accurate tracking of budget and approved scope.

• Track key program cost drivers that could affect timeline, budget, or capacity planning and report variances to the project team.

Continuous Improvement

• Capture lessons learned throughout the project lifecycle and contribute to improving the ADD Playbook, templates, and processes.

• Provide feedback to the Sr. Clinical Program Manager and Project Management team on process gaps, operational challenges, and improvement opportunities identified during project execution.

• Coordinate with internal change control proces