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 Principal Clinical Study Manager is a senior individual contributor role provides leadership and strategic oversight for the global execution of complex Companion Diagnostics (CDx) clinical studies. This role will specifically support Leica Biosystems, an operating company of Danaher Diagnostics. As the Principal Clinical Study Manager, you will independently lead end-to-end study planning and operational delivery, ensuring alignment with regulatory requirements, timelines, and quality standards. You will serve as the central point of accountability for study execution, collaborating cross-functionally and with external partners to drive progress, resolve issues, and achieve critical program milestones.
This position reports to the Director, Clinical Development and is part of the Global Clinical Affairs Team located in Newcastle, UK and will be an on-site role.
In this role, you will have the opportunity to:
Lead global IVD clinical development programs from concept to commercialization, ensuring strategic alignment with corporate goals, regulatory requirements, and portfolio priorities.
Oversee cross-functional site and vendor strategy, including selection, contract negotiation, performance management, and issue resolution to support enterprise-wide clinical trial execution.
Develop and implement operational frameworks integrating timelines, budgets, resource planning, and risk management to drive efficient and compliant program delivery.
Establish governance and communication structures to align internal and external stakeholders, promote transparency, and foster a collaborative, accountable culture.
Drive performance analytics and quality assurance, leveraging data insights to optimize trial execution, support regulatory submissions, and ensure audit readiness.
The essential requirements of the job include:
Bachelor’s degree in Life Sciences, Healthcare, or a related field with 10+ years’ experience in clinical research, specifically with significant experience in US and/or EU trials, or a Masters or Doctoral degree with 8+ years of same experience. In-depth understanding of clinical study execution in the diagnostics, medical device, or pharmaceutical industry with products intended for the US and EU markets. Demonstrated ability to identify and solve complex issues in clinical trial conduct and scientific interpretation Ability to critically review and interpret scientific and clinical trial data, and oversee the scientific aspects of study protocols and reports Excellent leadership, communication (written and verbal) and interpersonal skills for managing a team and collaborating with cross-functional stakeholdersIt would be a plus if you also possess previous experience in:
Experience in study designs for in vitro diagnostic technologies (IVD) is highly preferred, specifically for Digital Pathology and Immunohistochemistry (IHC) & In Situ Hybridization (ISH). Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs Professional certification in Clinical Research (e.g., SoCRA, ACRP).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.
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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.
Read LessBring 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 Principal Research and Development Scientist – Advanced Staining Reagents is responsible for technical input into the development of immunohistochemistry technology and advanced staining reagent products with a particular focus on Companion Diagnostics and interactions with Pharma Partners. In this role you will use your experience to steer, guide, and define processes and work.
This position reports to the R&D Manager and is part of the Research and Development (R&D) team located in Newcastle, UK and will be an on-site role.
In this role, you will have the opportunity to:
Make technical recommendations that contribute to the future strategy, working with internal and external stakeholders to further develop ideas towards potential future development projects. Be instrumental in the set-up and running of the Companion Diagnostics projects and providing clear guidance over possible path forwards. Provide guidance and best practice for engaging with Pharma partners and the process of managing those partners.Responsible for review and approval of technical project outputsProvide guidance and mentorship across the department for all projects as required.The essential requirements of the job include:
Significant R&D experience in immunohistochemistry, histopathology, chemistry, pathology imaging staining.Experience in working to develop Companion Diagnostics products, ideally within an R&D environment.Experience in working with, and managing expectations of, external stakeholders including Pharma.Experience working within the FDA and BSI regulatory environment.Ability to develop competence in others by serving as a technical mentor to the broader R&D team.It would be a plus if you also possess previous experience in:
Troubleshooting complex scientific/technical problems.Generation of a wide professional network.Managing aspects of technical project work.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.
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.
Read LessBring 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 Principal Specialist, Quality Assurance (Design) for Leica Biosystems is responsible for delivering and sustaining advance staining reagents and diagnostic assays into the Clinical Market.
This position reports to the Director, Quality Assurance & Regulatory Compliance and is part of the Quality Assurance and Regulatory Compliance Department located in Newcastle-upon-Tyne and will be an on-site position.
In this role, you will have the opportunity to:
Work on site projects to support the progression of the most viable commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM).Provide Design Control leadership across or within function, working with other LBS and Danaher sites.Work independently and with project team members to develop and improve processes to reduce variability and increase robustness throughout the development and product lifecycle for multiple projects.May lead functional teams or projects with moderate resource requirements, risk, and/or complexityWork closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications.The essential requirements of the job include:
Strong working knowledge of Design Controls & Design/Development practices for regulated products.Extensive experience in IVD medical device new product development and design controls.Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, ISO 14971 & MDSAP.Quality leadership experience with IVD medical devices. Bachelor’s degree in science, medical or technical field and experience with increasing responsibility in medical device Quality AssuranceTravel, Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel – up to 20% travelIt would be a plus if you also possess previous experience in:
Experienced in delivering higher classification medical devices and/or companion diagnostic products to market.Supplier Auditing and/or Quality Assurance.Experience with the MDSAP ProgrammeJoin 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.
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