CDx Program Manager

4 days ago


Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

Join to apply for the CDx Program Manager role at Leica BiosystemsBring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Leica Biosystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.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” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact.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.Responsible for working with key stakeholders, cross functional, global teams to mitigate and resolve issues, ensure task completion by establishing priorities and reaching compromise with team members and functional managers to make critical decisions to ensure project success.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 , we will however consider remote applications with the right experience, with the expectation of frequent (weekly travel) to our Leica Biosystems Newcastle Innovation Centre.In This Role, You Will Have The Opportunity ToLead and deliver complex CDx and R&D programs within the PMO by providing strategic oversight, cross-functional alignment, and direct line managementEffectively partner with pharma collaborators, internal teams, and business stakeholders to align on CDx co-development milestones alongside the CDx BD and alliance management team, ensuring clear, consistent communication of timelines, deliverables, and risks to all stakeholdersFully accountable for driving, tracking, and reporting project progress, risks, countermeasures, and issues to pharma partners. Ensure clear alignment between current project status and strategic objectives. Monitor trends in project performance and ensure timely escalation and resolution of issues.Develop and implement standard project management practices using Danaher Business System (DBS) principles, ensuring consistent delivery, ability to run Daily Management across all levels of program and project 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.The Essential Requirements Of The Job IncludeProven track record of ability to deliver CDx projects on time, in full and within budget, through the full project lifecycle, including feasibility, assay design and development, clinical validation and regulatory submission within highly regulated environments.Educated to BSc level in a relevant discipline or equivalentRelevant experience of working within medical device, class II or class III (or equivalent) and associated regulatory frameworks.Ability to identify, apply and manage best practice in project management principles.Exceptional communication skills (verbal/written/presentation/relationship building)Rapid learning ability to deal with complex and novel situationsLeica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.We are an equal opportunities employer and welcome applications from all qualified individuals. #J-18808-Ljbffr


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