Medical Director, Companion Diagnostics and Advanced Assays

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 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.

Learn about the Danaher Business System which makes everything possible.

The Medical Director, Companion Diagnostics and Advanced Assays for Leica Biosystems is responsible for providing medical and clinical leadership in the development of novel diagnostic and companion diagnostic assays and platforms to support precision medicine initiatives, positioning Leica Biosystems (LBS) as cutting-edge cancer diagnostics provider and pharma partner.

This position reports to the Senior Medical Director, Companion Diagnostics and is part of the MSA located in Newcastle Upon Tyne, UK and will be a hybrid on-site/remote role. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.

You will serve as critical leader for the teams involved in the development of Advanced Assays, Companion Diagnostic and Pharmaceutical Partnerships, and you'll be expected to provide pathology input to cross-functional teams and projects related to novel diagnostics. The role reports to the Senior Medical Director, Companion Diagnostics. If you thrive in a fast-paced, global role and want to work to build a world-class Diagnostics and Companion Diagnostics platform at LBS-read on.

In this role, you will have the opportunity to:

• Partner cross-functionally to collect, evaluate and communicate key clinical, medical and scientific data. You will be the Subject Matter Expert to direct R&D projects, clinical studies, and regulatory submissions in support of diagnostic and companion diagnostic assays. You will be responsible for providing strategic insight to support new product development and innovation opportunities, prioritizing opportunities based on clinical value and strong medical understanding of pharma, physician and patient needs.
• Actively support pharma partnerships (companion diagnostics), clinical evidence generation partnerships, and strategic growth efforts through collaboration with internal teams and cultivation of relationships in pathology practice (academic and community) and pharma.
• Play an integral role in building LBS’s brand as a pharma partner and thought leader in advanced assays. Provide internal and external education and expertise to support product innovation and market adoption of best practices and new technologies in a variety of settings, including conferences, webinars, and site visits.
• Provide pathology expertise and medical insight for the development of assay design specifications; design and execution of IVD and CDx studies; creation of training materials and interpretation guides; contribution to regulatory strategy and submissions; participation in meetings with regulators (e.g. FDA); review of marketing and promotional materials.
• Provide medical input to device risk analyses, health hazard evaluations (HHE), adverse event review, and risk/benefit reporting.

The essential requirements of the job include:

• PhD qualified Pathologist with advanced scientific training and experience, with track record of quality publications.
• Board certification (FRCPath Parts 1 and 2) in Histopathology
• Full GMC registration, license to practice, and Specialist Register entry in Histopathology
• >2 years of experience in diagnostics, laboratory, biopharma, medical device, or related industry.
• Experience in the development of in vitro diagnostic products including interactions with regulatory agencies.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel - 30-40% travel, including international

It would be a plus if you also possess previous experience in:

• PhD in a scientific discipline with advanced scientific training and experience, with track record of quality publications.
• Additional training in pathology subspecialty such as molecular genetic pathology, hematopathology, or clinical informatics; other organ-specific Histopathology specialty training in areas such as GI, GU, or breast.
• Experience in computational pathology and clinical informatics, machine learning, and artificial intelligence as applied to digital pathology research and practice.
• Experience with risk management / safety assessment in medical device or biopharmaceutical industry.
• Experience with product development and/or business development and strategy in medical device or biopharmaceutical industry.
• Creative problem-solver with the ability to spot issues of significant importance early and partner with colleagues to help solve them.
• Strong written and verbal communication skills; ability to act as a change agent through dynamic interactions with others; ability to give persuasive and engaging presentations to audiences with varying backgrounds.
• Ability to work via influence in a global, matrixed, multidisciplinary organization.
• Strong relationship management skills: ability to build and maintain productive relationships with leaders of other functional areas within and across the business areas to seek alignment on objectives for the benefit of Leica Biosystems.
• Demonstrated ability to manage and prioritize multiple projects. Highly motivated with the ability to be proactive, take initiative, and carefully monitor, follow through, and complete projects in a professional and timely manner.
• Professional maturity and confidence in expressing a point of view with management and external partners.

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 Danaher Benefits Info.

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 www.danaher.com.