Project Manager, Companion Diagnostics; CDx

Position: Project Manager, Companion Diagnostics (CDx)
Companion Diagnostics (CDx) Project Manager

Contract Role | Hayward, CA (Onsite Preferred) Remote option available for highly experienced candidates

Overview

Predicine is seeking a highly skilled and collaborative Companion Diagnostics (CDx) Project Manager at the Manager or Associate Director level to lead complex CDx development programs from feasibility through analytical/clinical validation and regulatory submission. This role sits at the strategic intersection of CDx development, pharmaceutical partnerships, operational execution, and regulatory pathways.

The ideal candidate will excel in cross-functional leadership, program oversight, timeline and risk management, and partner engagement. This position will support all facets of CDx development, including budgeting, invoicing, resource planning, and coordination across global internal teams and external collaborators.

This is a contract-based, full-time role with potential for extension or transition to a permanent position.

Key Responsibilities

Project Leadership & Stakeholder Management

• Lead and manage global, cross-functional project teams spanning scientific, clinical, operational, commercial, and regulatory disciplines.

• Act as the central point of contact for internal stakeholders, senior leadership, and external partners.

• Drive execution of CDx development programs, ensuring adherence to scope, timelines, quality standards, and budget.

• Oversee multiple complex initiatives simultaneously, including global co-development programs.

Program Planning, Tracking & Risk Management

• Develop and maintain detailed project plans, schedules, Gantt charts, resource needs, and task lists.

• Identify, assess, and manage project risks using structured methodologies; implement mitigation strategies to avoid delays.

• Perform scenario analyses to support strategic decision-making for leadership and partners.

• Track program budgets, monitor variances, and communicate financial impacts proactively.

Meeting Leadership & Communication

• Lead effective project meetings, prepare agendas, document key decisions, track risks, and monitor action items.

• Deliver clear and consistent communication to internal teams, external partners, and leadership.

• Provide frequent status updates, milestone tracking, and risk summaries.

• Influence cross-functional strategy and drive alignment across multiple organizational levels.

Collaboration With IVD/CDx Development Teams

• Partner closely with Companion Diagnostics Development, R&D, Clinical Development, and other functions to support assay development, analytical validation, clinical validation, and regulatory activities.

• Coordinate project elements supporting FDA PMA submissions, global regulatory filings, and pharma co-development programs.

• Support technology transfer, manufacturing readiness, and commercialization planning for CDx products.

Qualifications & Skills

Technical & Industry Background

• 8+ years of project/program management experience in diagnostics, medical devices, pharma, or biotechnology.

• Hands-on experience with CDx development, IVD development, or clinical biomarker programs.

• Experience with NGS-based or liquid biopsy platforms strongly preferred.

• Familiarity with analytical & clinical validation workflows and global regulatory submissions (FDA, ex-US agencies).

• Direct PMA submission experience is highly preferred.

• Strong understanding of regulated environments, including 21 CFR 820, ISO 13485, and ISO 9001.

• Experience working within pharma co-development frameworks is a plus.

Project Management Skills

• Exceptional organizational, prioritization, and multitasking abilities across multiple complex programs.

• Strong stakeholder management, influence leadership, and conflict resolution skills.

• Excellent verbal and written communication for technical, cross-functional, and executive audiences.

• Proficiency with MS Project, Smartsheet, or similar Gantt-based project tools.

• PMP certification strongly preferred.

Education

• Bachelor's or Master's degree (or equivalent experience) in a relevant field such as biological sciences, biotechnology, life sciences, or bioengineering.

Contract Details

• Type:
Independent Contractor / Consultant

• Duration: 12 months, with potential extension or conversion

• Commitment:
Full-time

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Location:

Onsite preferred (Hayward, CA); remote available for candidates with strong CDx or PMA experience