CDx Program Manager

Danaher

  • Newcastle
  • Permanent
  • Full-time
  • 27 days ago
Bring 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 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.Learn about the which makes everything possible.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 to:
  • Lead and deliver complex CDx and R&D programs within the PMO by providing strategic oversight, cross-functional alignment, and direct line management
  • Effectively 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 stakeholders
  • Fully 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 include:
  • Proven 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 equivalent
  • Relevant 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 situations
Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
  • Travel expectations within this role are project specific and commonly ~30%, this will include overnight stays and potential international travel.
It would be a plus if you also possess previous experience in:
  • PMP/Prince2 certification is preferred
  • 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 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. Check out our benefits at .At Leica Biosystems, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.For more information, visit .At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Danaher