Global Project Manager- Personalized Healthcare

Pharmaceutical Company; Tucson (AZ); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Pharmaceutical Company in Tucson, AZ is seeking a Global Project Manager for Personalized Healthcare Solutions, focusing on Companion Diagnostics (CDx). Hybrid work with ~2 days onsite weekly.

You will lead complex product development from concept to regulatory submission and launch, coordinating R&D, regulatory, QA, and external partners. The role demands a strong background in project management within diagnostics/pharma/biotech, with experience in budgets, timelines, risks, and regulatory

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or Business.
• 4+ years in project management in diagnostics/pharma/biotech.
• Experience in regulatory submissions and validation.
• Familiarity with FDA 21 CFR Part 820, ISO 13485/9001.

Responsibilities

• Lead CDx projects from concept to launch with external partners.
• Develop and maintain project plans, timelines, and budgets.
• Coordinate cross-functional teams across R&D, regulatory, QA, and manufacturing.
• Ensure compliance with quality systems and regulatory requirements.
• Report status to stakeholders and manage risks.

Skills

Project management

Cross-functional leadership

Regulatory compliance

Budget management

Agile & Waterfall

Vendor coordination

Education

Bachelor's degree

Tools

Planisware

Google Workspace

Microsoft Office

Job description

Global Project Manager - Personalized Healthcare Solutions

Location: Tucson, AZ (Hybrid, approximately 2 days onsite per week)

Position Overview

We are seeking an experienced Global Project Manager to lead complex product development projects within Personalized Healthcare Solutions, with a focus on Companion Diagnostics (CDx). This role will manage projects from initial concept through development, validation, regulatory submission, and launch while coordinating cross-functional teams and external pharmaceutical partners.

The ideal candidate will have a strong background in project management within the pharmaceutical, biotechnology, in vitro diagnostics (IVD), or medical device industry, along with experience managing project schedules, budgets, resources, risks, and regulatory requirements.

Important location requirement: Candidates must currently reside in Tucson or the surrounding vicinity, including Oro Valley, Marana, Catalina, Vail, or South Tucson. Candidates located in Phoenix will not be considered.

Key Responsibilities

• Lead and manage Companion Diagnostics (CDx) projects from conception through product launch in collaboration with external pharmaceutical partners.
• Develop and maintain comprehensive project plans, timelines, critical paths, milestones, dependencies, and resource allocation plans.
• Manage project scope, budgets, forecasts, FTE requirements, and change control processes.
• Coordinate cross-functional teams across R&D, clinical development, regulatory affairs, quality, manufacturing, and other relevant functions.
• Establish and lead project meetings, stakeholder reviews, status updates, and executive reporting.
• Identify, assess, and mitigate project risks, issues, and dependencies to ensure successful delivery.
• Monitor partner and vendor deliverables, contractual milestones, timelines, and invoice forecasts.
• Ensure project activities comply with applicable quality management systems and regulatory requirements.
• Drive effective communication and alignment between internal stakeholders and external pharmaceutical partners.
• Apply appropriate project management methodologies, including hybrid Waterfall and Agile approaches, to deliver project objectives.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Business, or a related field.
• Minimum of 4 years of relevant experience in project management, engineering, or business within diagnostics, medical devices, pharmaceuticals, or biotechnology, with involvement in product development or product lifecycle management.
• At least 1 year of experience in one or more of the following areas:
• Analytical or clinical validation
• Regulatory submissions
• Relevant program or project management
• At least 1 year of experience working in a regulated industry, with familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 9001, or comparable quality standards.
• Demonstrated experience managing project timelines, budgets, resources, risks, scope, and cross-functional dependencies.
• Experience coordinating external partners, vendors, or stakeholders in complex product development environments.
• Proficiency with Microsoft Office and project management tools.
• Strong communication, organizational, analytical, and stakeholder management skills.

Preferred Qualifications

• Master's degree with at least 6 years of relevant experience, or PhD with at least 3 years of relevant experience.
• Three or more years of experience in CDx/IVD development, clinical or analytical validation, regulatory submissions, instrument development, or related program management.
• Experience managing complex co-development programs with external pharmaceutical partners.
• Familiarity with Planisware, Google Workspace, and other project planning and tracking platforms.
• Project Management Professional (PMP) certification.
• Experience with Agile methodologies, SAFe, or hybrid Waterfall-Agile project environments.

Ideal Candidate Profile

The ideal candidate is a hands-on project manager with direct experience leading regulated diagnostic or pharmaceutical product development projects. They should be comfortable coordinating multidisciplinary teams, managing budgets and resources, working with external pharmaceutical partners, and driving projects through key development and launch milestones.

Work Arrangement: Hybrid, approximately 2 days onsite per week in Tucson, Arizona. Candidates must meet the specified local residency requirement.