Global Project Manager – Personalized Healthcare Solutions
Location: Tucson, AZ Area (Hybrid)
Schedule: Hybrid; approximately 2 days onsite per week in Oro Valley, AZ
Employment Type: Contract
Drive Innovation in Personalized Healthcare
We are seeking an experienced Global Project Manager – Personalized Healthcare Solutions to lead complex Companion Diagnostics (CDx) and product development initiatives within a highly collaborative biotechnology and healthcare environment. In this role, you will oversee projects from concept through commercialization, partnering with internal cross-functional teams and external pharmaceutical organizations to deliver high-impact healthcare solutions. The ideal candidate brings strong biotech, pharmaceutical, diagnostics, or medical device project management experience and a proven ability to lead programs involving regulatory, clinical, scientific, and commercial stakeholders.
Important: Candidates must reside in the Tucson, Arizona area or nearby communities, including Oro Valley, Marana, Catalina, Vail, or South Tucson. This position is not intended for candidates based in Phoenix.
Please Note This position requires true project management experience within biotech, pharmaceutical, diagnostics, medical device, or related life sciences industries. Candidates whose experience is exclusively in IT, software, or technology project management will not be considered.
Key Responsibilities
- End-to-End Project Leadership: Lead Companion Diagnostics (CDx) development projects from initiation through launch. Drive project execution in partnership with external pharmaceutical collaborators and internal stakeholders. Develop and manage project plans, schedules, budgets, resource strategies, and status reporting.
- Schedule & Deliverables Management: Build and maintain integrated project timelines using tools such as Planisware. Identify critical path activities, manage dependencies, and remove obstacles to ensure milestone achievement. Facilitate proactive decision-making to maintain project momentum and contractual commitments.
- Resource & Budget Management: Coordinate with functional leaders to secure and optimize project resources. Monitor team utilization, project expenditures, FTE allocations, and overall budget performance. Prepare exception analyses and provide recommendations to business and finance stakeholders.
- Scope, Risk & Change Management: Define project objectives, scope baselines, and success criteria. Manage changes to project scope, timelines, budgets, and resources through structured change-control processes. Identify project risks, develop mitigation strategies, and maintain contingency plans. Conduct impact assessments and elevate issues appropriately.
- Stakeholder & Partner Management: Lead project team meetings with internal stakeholders and external pharmaceutical partners. Foster alignment, resolve conflicts, and ensure effective communication across all project participants. Track contractual obligations, forecast invoices, and communicate project status updates.
- Quality & Compliance: Ensure project execution aligns with Quality Management System (QMS) requirements and applicable regulatory standards. Support lessons learned activities and continuous improvement initiatives. Maintain accurate project data and reporting to drive informed decision-making and operational excellence.
- Project Methodology & Execution: Apply appropriate project management methodologies, including Agile, Hybrid Agile-Waterfall, and SAFe practices. Oversee work breakdown structures (WBS), milestone reviews, capacity planning, and project closeout activities.
- Serve as a trusted advisor, delivering strategic insights that maximize project value and organizational effectiveness.
Required Qualifications
- Bachelor's degree, preferably in a Life Sciences discipline.
- Minimum 4 years of project management, engineering, or business experience within biotechnology, pharmaceuticals, diagnostics, or medical devices.
- Experience leading product development and product lifecycle initiatives.
- At least 1 year of experience in one or more of the following: Companion Diagnostics (CDx) In Vitro Diagnostics (IVD) Clinical biomarker development Analytical or clinical validation Regulatory submissions Instrument or system development Program management Experience working within regulated environments, including FDA and ISO-regulated industries.
- Proficiency with Planisware, Microsoft Office, Google Workspace, and project management tools such as Jira, Smartsheet, Trello, Lucidchart, and Azure DevOps.
- Knowledge of Agile methodologies, SAFe frameworks, and hybrid project delivery environments.
Preferred Qualifications
- Master's degree with 6+ years of relevant industry experience, or PhD with 3+ years of project management experience.
- Advanced experience in CDx, IVD, biomarker development, clinical validation, regulatory submissions, or instrument development.
- Proven success managing complex global programs involving external co-development partners.
- PMP and/or SAFe Agile certification.
Keywords for Search Visibility
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