CDx Program Manager

Overview

The Program Manager, Companion Diagnostics (CDx) is responsible for leading the successful delivery of pharma-partnered programs and projects, specializing in Companion Diagnostics and Advanced Assay development. This position reports to the Director, PMO, EHS and Facilities and is part of the Project Management team. Ideally the role will be located onsite at our Leica Biosystems Newcastle Innovation Centre, in Newcastle Upon Tyne, UK; remote applications with the right experience will be considered, with the expectation of frequent (weekly) travel to the Newcastle Innovation Centre.

At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” drives everything we do. You’ll be part of a diverse, collaborative global community, helping turn ideas into impact and innovating at the speed of life.

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Responsibilities

• Lead and deliver complex CDx and R&D programs within the PMO by providing strategic oversight, cross-functional alignment, and direct line management.
• Partner effectively with pharma collaborators, internal teams, and business stakeholders to align on CDx co-development milestones with the CDx BD and alliance management team, ensuring clear communication of timelines, deliverables, and risks to all stakeholders.
• Drive, track, and report project progress, risks, countermeasures, and issues to pharma partners; ensure alignment between current status and strategic objectives; monitor trends and escalate/resolution of issues promptly.
• Develop and implement standard project management practices using Danaher Business System (DBS) principles, enabling Daily Management across all levels of program delivery while integrating Quality, Regulatory, and EHS requirements.
• Provide leadership, mentoring, and coaching to project teams, fostering talent development and building organizational project management capability through training and continuous improvement.

Essential requirements

• Proven track record of delivering CDx projects on time, within budget, across the full project lifecycle (feasibility, assay design and development, clinical validation, regulatory submission) in highly regulated environments.
• Educated to BSc level in a relevant discipline or equivalent.
• Relevant experience within medical devices (class II or III or equivalent) and applicable regulatory frameworks.
• Ability to identify, apply, and manage best practices in project management principles.
• Exceptional communication skills (verbal, written, presentation, relationship-building).
• Rapid learning ability to handle complex and novel situations.

Travel and physical/environment requirements

Travel expectations are project-specific and commonly ~30%, including overnight stays and potential international travel.

Desirable experience

• PMP/Prince2 certification is preferred.
• Experience managing cross-functional teams across biomarker research, regulatory, clinical operations, and medical affairs.
• Hands-on experience with clinical trial assay implementation, including working with reference labs and centralized testing vendors.

Leica Biosystems, a Danaher operating company, offers comprehensive benefits and flexible, remote work arrangements where eligible. This position is eligible for remote work from home; additional information will be provided by the interview team. For more information, visit www.danaher.com.