Negotiable
Overview
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 united by a shared commitment to innovate for tangible impact.You’ll thrive in a culture of belonging where your unique viewpoint matters. 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 shaping the future of cancer diagnostics and transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” drives our work. As a global leader with a comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers. You’ll join a passionate team that values every moment when it comes to cancer and helps accelerate next-generation, life-changing therapies. Surrounded by a diverse, collaborative global community, you’ll be inspired to grow and make an impact.Learn about the Danaher Business System which makes everything possible.Position
Principal Clinical Study Manager
is a senior individual contributor role providing 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. 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.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.Responsibilities
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.Essential qualifications
Bachelor’s degree in Life Sciences, Healthcare, or a related field with 10+ years’ experience in clinical research, or a Master/Doctoral degree with 8+ years of similar experience, including US and/or EU trials.In-depth understanding of clinical study execution in the diagnostics, medical device, or pharmaceutical industry with products for 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 stakeholders.PlusExperience in study designs for in vitro diagnostic technologies (IVD), specifically for Digital Pathology and Immunohistochemistry (IHC) and In Situ Hybridization (ISH).Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.Professional certification in Clinical Research (e.g., SoCRA, ACRP).Benefits
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Check out our benefits information.#LI-OnsiteJoin 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 ..... full job details .....
Negotiable