Global Project Manager

• Companion Diagnostics (CDx) Project Ownership: You will proactively drive, from conception to launch, the development activities for CDx Development projects in close collaboration with third-party Pharmaceutical partners.
• Schedule Management: You will proactively own timeline creation and management during scoping and post-contract execution using industry-standard tools such as Planisware. You 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: You 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: You will drive the project budget from initial scoping through post-contract execution. You 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: You will define project objectives and establish scope baselines. You will proactively identify and address any deviations in scope, budget, timeline, and resources using our change management process, and conduct comprehensive impact assessments. You will review Pharma-driven change requests with senior project stakeholders to determine if project contract amendments are necessary.
• Stakeholder & Communication Management: You will own project team meetings amongst internal members as well as with Pharma partners to ensure the delivery of CDx contract milestones. You will partner with the project team to engage stakeholders through appropriate channels, resolve conflicts, and secure acceptance from key project stakeholders
• Project Risk Management: You will proactively identify, evaluate, and prioritize project risks, engaging stakeholders to co-develop mitigation strategies and contingency plans. You will regularly review risks with your project team, and provide comprehensive risk reports to stakeholders to ensure informed decision-making.
• Quality Management & Project Health: You will partner with Quality stakeholders to ensure project execution is in compliance with our Quality Management System (QMS) framework and regulatory guidelines. You will conduct lessons learned activities to drive continuous improvement and provide insights for future projects. You 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: You will facilitate effective collaboration, information flow, and decision-making with external Pharma entities. You will ensure all contract milestones are accurately tracked and status communicated to key internal stakeholders. You will own the communication of invoice forecasts to Pharma partners.
• Methodology & Execution: You will select and apply appropriate project methodologies, including hybrid Agile practices and Scaled Agile Framework (SAFe) where applicable. You 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.

• You hold a Bachelor’s degree, preferably in a Life Sciences field.
• You have 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.
• You have at least one year of experience in the following areas: clinical biomarker or In Vitro Diagnostic development, CDx development, analytical and clinical validations, regulatory submissions, instrument/systems development, or program management.
• You have one year of experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).
• You are proficient and have demonstrated experience using Planisware, MS Office, and Google Suite, and “know-how” of project management tools such as Trello, LucidChart, Smartsheet, Jira, Azure DevOps, etc.
• You have working knowledge on Agile best practices and Agile-at-Scale methodologies (e.g SAFe), and have experience operating in hybrid Waterfall-Agile environments.

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

Salary : $62