Global Project Manager- Personalized Healthcare

Pay Range: $57.00hr - $62.00hr

Job Overview:

As part of the Project Management Chapter, the Global Project Manager (GPM) plays a key role in optimized product delivery and is accountable for all project management aspects of various projects from simple to complex in nature. The GPM drives projects from original concept through completion by developing and directing detailed work plans, schedules, project estimates, spending, resource plans, and status reports. As a trusted advisor, the GPM translates and drives projects into products and enables the organization to use energy and time effectively and efficiently while quickly responding to changing business needs across the portfolio.

Duties:

• The GPM drives the project from the original concept through completion by developing and directing detailed work plans, schedules, project estimates, spending, resource plans, and status reports.

The Opportunity:

• Companion Diagnostics (CDx) Project Ownership: The candidate will proactively drive, from conception to launch, the development activities for CDx Development projects in close collaboration with third-party Pharmaceutical partners.
• Schedule Management: The candidate will proactively own timeline creation and management during scoping and post-contract execution using industry-standard tools such as Planisware.
• The candidate will analyze the project critical path to determine priorities and drive team discussions, resolve dependencies and roadblocks, and guide the team to achieve key CDx contract deliverables.
• Resource Management: The candidate will collaborate with project team members and key functional stakeholders to identify project resource needs, align functional leaders on resource availability, and continuously monitor usage and performance to optimize team allocation and proactively escalate concerns.
• Budget Management: The candidate will drive the project budget from initial scoping through post-contract execution. The candidate will perform regular monitoring and maintenance of the budget with key functional stakeholders, prepare exception analyses for business and finance stakeholders, and track FTEs and project expenditures.
• Scope & Change Management: The candidate will define project objectives and establish scope baselines.
• The candidate will proactively identify and address any deviations in scope, budget, timeline, and resources using the organization's change management process, and conduct comprehensive impact assessments. The candidate will review Pharma-driven change requests with senior project stakeholders to determine if project contract amendments are necessary.
• Stakeholder & Communication Management: The candidate will own project team meetings amongst internal members as well as with Pharma partners to ensure the delivery of CDx contract milestones.
• The candidate will partner with the project team to engage stakeholders through appropriate channels, resolve conflicts, and secure acceptance from key project stakeholders.
• Project Risk Management: The candidate will proactively identify, evaluate, and prioritize project risks, engaging stakeholders to co-develop mitigation strategies and contingency plans.
• The candidate will regularly review risks with the project team, and provide comprehensive risk reports to stakeholders to ensure informed decision-making.
• Quality Management & Project Health: The candidate will partner with Quality stakeholders to ensure project execution is in compliance with the Quality Management System (QMS) framework and regulatory guidelines. The candidate will conduct lessons learned activities to drive continuous improvement and provide insights for future projects.
• The candidate will maintain high project data quality to enable teams to recognize recurring issues, pinpoint their root causes, and promote ongoing learning and process optimization.
• Partner & Vendor Management: The candidate will facilitate effective collaboration, information flow, and decision-making with external Pharma entities.
• The candidate will ensure all contract milestones are accurately tracked and status communicated to key internal stakeholders.
• The candidate will own the communication of invoice forecasts to Pharma partners.
• Methodology & Execution: The candidate will select and apply appropriate project methodologies, including hybrid Agile practices and Scaled Agile Framework (SAFe) where applicable. The candidate will manage WBS creation and closeout, oversee milestone and capacity reviews, and act as a trusted advisor with a 360 view to support holistic planning and optimized value delivery.
• Other duties as assigned by leadership.

Candidate Profile:

• Bachelor's degree, preferably in a Life Sciences field.
• 4 years of experience in project management / engineering / business in the diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects.
• At least one year of experience in clinical biomarker or In Vitro Diagnostic development, CDx development, analytical and clinical validations, regulatory submissions, instrument/systems development, or program management.
• One year of experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).
• Proficient with demonstrated experience using Planisware, MS Office, and Google Suite, and knowledge of project management tools such as Trello, LucidChart, Smartsheet, Jira, Azure DevOps, etc.
• Working knowledge of Agile best practices and Agile-at-Scale methodologies (e.g. SAFe), and experience operating in hybrid Waterfall-Agile environments.

Preferred Qualifications:

• Master's degree, preferably in a Life Sciences field, and 6 years of project management / engineering / business experience in the diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects. Alternatively, a Ph.D. with 3 years of project management experience in those areas.
• 3 years of clinical biomarker or In Vitro Diagnostic development experience in CDx development, analytical and clinical validations, regulatory submissions, or instrument development and program management.
• Significant experience managing complex project team structures, including third-party external co-development partners.
• Project Management Professional (PMP) and/or SAFe Agile certifications.