Clinical Trials jobs in Newcastle upon Tyne

Senior Research and Development Scientist – Companion Diagnostics (CDx)

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

About the Role

The Senior Research and Development Scientist – Companion Diagnostics (CDx) is a key technical and project leadership role within Leica Biosystems’ Companion Diagnostics organisation. This position contributes to the development and validation of innovative immunohistochemistry (IHC) assays and staining solutions that support pharmaceutical partners in the development and commercialisation of targeted therapies.

Working within a cross-functional environment, you will lead technical projects from concept through delivery, collaborating closely with pharmaceutical partners, internal scientific experts, regulatory affairs, quality, operations, and commercial teams. You will play a critical role in ensuring successful execution of CDx programmes while advancing Leica Biosystems’ position as a leading cancer diagnostics partner.

This position is part of the Research & Development (R&D) organisation located in Newcastle and is an on-site role. You will be a member of the Companion Diagnostics (CDx) team and report to the R&D Manager. In this role, you will provide technical leadership for customer-facing projects and support the delivery of high-quality diagnostic solutions within a regulated environment.

In this role, you will have the opportunity to:

• Lead Companion Diagnostic development projects, coordinating activities across multidisciplinary teams to deliver project milestones on time and to quality standards.
• Partner directly with pharmaceutical customers to support the development of diagnostic assays that enable precision medicine and targeted cancer therapies.
• Serve as a scientific and technical expert for immunohistochemistry (IHC) assay development, optimisation and validation on automated staining platforms.
• Collaborate with internal Subject Matter Experts across Regulatory, Quality, Medical Affairs, Operations and Commercial functions to drive project success.
• Contribute to the development and launch of innovative diagnostic products that improve patient outcomes and support drug development programmes.
• Apply scientific expertise within a regulated environment, ensuring compliance with applicable quality and regulatory requirements.
• Support strategic initiatives that strengthen Leica Biosystems’ position as a leading partner for Companion Diagnostic development.

The essential requirements of the job include:

• Significant laboratory experience within a regulated environment, including strong knowledge of immunohistochemistry (IHC) techniques.
• Demonstrated experience leading scientific or technical projects and working effectively within cross-functional teams.
• Degree in a scientific discipline (or equivalent experience).
• Strong communication and stakeholder management skills, with the ability to engage effectively with both internal teams and external partners.
• Knowledge of Health & Safety requirements within laboratory environments.
• Experience delivering projects in a dynamic, fast-paced environment.

It would be a plus if you also possess:

• Extensive experience in Immunohistochemistry (IHC) assay development and validation.
• Experience working with Companion Diagnostics (CDx), in vitro diagnostics (IVD), pharmaceutical development programmes, or biomarker development.
• Experience interacting directly with external customers, pharmaceutical partners, CROs, or clinical research organisations.
• Knowledge of product development processes within regulated medical device or diagnostics environments.
• A higher degree (MSc or PhD) in a relevant scientific discipline.

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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.