Global Project Manager - Personalized Healthcare Solutions

Spectraforce Technologies, Inc.; Tucson (AZ); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Global Project Manager to lead CDx development programs in the Personalized Healthcare Solutions portfolio.

The role supports hybrid work with on-site presence in the Oro Valley area, coordinating cross-functional teams and external Pharma partners to deliver projects from concept to launch. The position emphasizes strong project management practices, regulatory awareness, and effective communication across stakeholders.

Qualifications

• Bachelor's degree, preferably in a Life Sciences field.
• 4+ years of experience in project management/engineering/business in diagnostic, medical device, pharmaceutical or biotech industries.
• At least 1 year in areas such as CDx development, regulatory submissions or instrument development; experience in a regulated environment (FDA 21 CFR 820, ISO 13485, ISO 9001).
• Proficiency with Planisware, MS Office, Google Suite; familiarity with Jira, Trello, LucidChart, Smartsheet, Azure DevOps.

Responsibilities

• Drive CDx development projects from concept to launch in collaboration with pharma partners.
• Own schedule creation and management using Planisware; manage critical path and resolve roadblocks.
• Collaborate with stakeholders to identify resources and optimize team allocation.
• Oversee project budget from scoping through execution and track expenditures.
• Define scope baselines and manage deviations using change processes; assess impact of changes.
• Lead project team meetings with internal and partner stakeholders to ensure milestones are met.
• Identify risks, develop mitigation plans, and report to stakeholders.
• Ensure alignment with QMS and regulatory guidelines; capture lessons learned.
• Coordinate with external partners to support contract milestones and invoicing.

Skills

Project management

Hybrid Waterfall-Agile

SAFe Agile

Vendor management

Education

Bachelor's degree (Life Sciences preferred)

Tools

Planisware

MS Office

Google Suite

Trello

LucidChart

Smartsheet

Jira

Azure DevOps

Job description

Position Title

Global Project Manager - Personalized Healthcare Solutions

Work Location

Tucson, Arizona, or the surrounding vicinity (e.g., Oro Valley, Marana, Catalina, Vail, South Tucson). Phoenix is NOT in the Tucson vicinity.

Assignment Duration

12 Months

Work Arrangement

Hybrid with on-site presence in the Oro Valley, AZ campus ~2 days/week.

Position Summary

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us The Organization.

Background & Context

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 the project from the 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.

Key Responsibilities

• 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 elevate 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.

Qualification & Experience

• 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.

Preferred Qualifications

• 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.

Additional Information (If Applicable)

REQUIRED CHARACTERISTICS

True project management experience in Biotech/Pharma space

EXCLUSIONS

only IT project management or software/tech project management background