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.The Senior Clinical Research Scientist for Leica Biosystems is responsible for developing and executing comprehensive clinical evidence plans to support global growth initiatives across multiple functions within Medical Device and IVD.This position is part of the Global Clinical Affairs organization, in support of the Advanced Assays and Pharma Services’ Companion Diagnostics (CDx) Center of Excellence located in Newcastle Upon Tyne, United Kingdom, and will be on-site following the hybrid model. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.You will be a part of the Clinical Affairs Strategy team and report to the Director, Clinical Affairs. If you thrive in a dynamic clinical programs leadership role and want to work to build a world-class CDx organization—read on.In this role, you will have the opportunity to:Apply Good Clinical Practice (GCP) expertise in the design of global evidence initiatives to support new product development, companion diagnostic programs, pre- and post-market studies, and internal evidence development processes.Drive execution of clinical evidence strategy plans through synthesis of Voice of Customer requirements into recommended evidence investments for all priority products and markets to meet customer needs and drive market awareness/adoption.Lead the development of study design documentation – protocol writing, enrollment strategy, collaboration on statistical analysis plan, data management plan, monitoring plan, etc., as well as the delivery of robust study outcomes – data analysis and presentation to internal and external stakeholders, clinical performance study/clinical investigation report writing, and peer-reviewed publications.Collaborate with internal project stakeholders (Product Management, R&D, Regulatory, Quality, Medical Affairs, Design Transfer, etc.) and external partners (such as pharma, co-development collaborators and CROs).Support the clinical operations team with the conduct of clinical studies.The essential requirements of the job include:Significant experience in evidence planning, clinical strategy, study design/execution and study monitoring for clinical diagnostics, medical devices, and/or pharmaceutical products in a regulated environment.Demonstrated experience in effectively negotiating with regulators (such as the U.S. Food and Drug Administration, European Medicines Agency, EU Notified Bodies) regarding high-classification clinical programs resulting in successful global commercial releases.Demonstrated ability to secure appropriate internal or external technical expertise required, build strong alliances, and coordinate efforts to resolve difficult technical and/or compliance issues that may arise during clinical trials.Demonstrated ability to understand complex scientific and business concepts.It would be a plus if you also possess previous experience in:Oncology, histopathology, IHC RNA, ISH and DNA ISH assays and reagents, digital pathology imaging.Clinical research certification.A global matrix work environmentAt Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. 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.
