Global Project Manager - Personalized Healthcare

We are seeking a Global Project Manager that will lead Companion Diagnostics (CDx) development projects from initial planning through execution and launch in collaboration with pharmaceutical partners and cross-functional teams. At least 1 year of experience in CDx, IVD, clinical biomarker development, analytical or clinical validation, regulatory submissions, instrument development, or program management.

Global Project Manager – Personalized Healthcare Solutions
Location: Tucson, Arizona (Hybrid)
Pay Rate: $62/hr
1 year contract with potential for extension and/or permanent placement
Weekly pay and healthcare benefits!

Position Overview
We are seeking a Global Project Manager that will lead Companion Diagnostics (CDx) development projects from initial planning through execution and launch in collaboration with pharmaceutical partners and cross-functional teams. Responsibilities include project planning, scheduling, budgeting, resource allocation, risk management, scope control, stakeholder communication, and regulatory compliance.
Key Responsibilities

• Lead CDx and product development projects from conception through completion.
• Develop and manage project plans, schedules, budgets, resource allocations, and milestones.
• Monitor project performance, critical paths, expenditures, and resource utilization.
• Manage project scope, change requests, risks, dependencies, and mitigation strategies.
• Coordinate cross-functional teams, pharmaceutical partners, and external vendors.
• Ensure compliance with applicable quality management systems and regulatory requirements.
• Prepare project status reports, budget forecasts, risk assessments, and stakeholder updates.
• Apply project management methodologies, including hybrid Waterfall-Agile and SAFe, as appropriate.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Business, or a related field; Life Sciences preferred.
• At least 4 years of project management, engineering, or business experience in biotechnology, pharmaceuticals, diagnostics, or medical devices.
• At least 1 year of experience in CDx, IVD, clinical biomarker development, analytical or clinical validation, regulatory submissions, instrument development, or program management.
• At least 1 year of experience in a regulated industry.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, or ISO 9001.
• Proficiency with Planisware, Microsoft Office, and Google Workspace.
• Familiarity with project management tools such as Smartsheet, Jira, Trello, Lucidchart, or Azure DevOps.
• Knowledge of Agile, SAFe, and hybrid Waterfall-Agile methodologies.

Preferred Qualifications

• Master's degree with 6 years of relevant industry experience, or Ph.D. with 3 years of relevant project management experience.
• At least 3 years of experience in CDx, IVD, clinical biomarker development, validation, regulatory submissions, or instrument development.
• Experience managing complex cross-functional teams and external pharmaceutical partnerships.
• PMP and/or SAFe certification.

At Tailored Management, we help people get jobs and take pride in their work, so we better take pride in ours too. Not every company has the opportunity to meaningfully and directly impact individuals in a way that makes their lives tangibly better. To better support our employees, we offer a wide variety of benefit options to support you. We offer:

Medical Coverage – HDHP, PPO, and Surest plan options
Minimum Essential Coverage (MEC)
Dental Insurance
Vision Insurance
Short-Term Disability (STD)
Long-Term Disability (LTD)
Life & AD&D Insurance
Critical Illness Insurance
Accident Insurance
Employee Assistance Program (EAP)
 
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