Principal Scientist, Clinical Research - Remote UK

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.

This senior individual contributor role is responsible for defining global clinical evidence strategies with a strong focus on EU IVDR compliance. This role supports Leica Biosystems, an operating company of Danaher Diagnostics, and plays a critical role in ensuring that clinical performance and post‑market evidence generation meet evolving regulatory expectations.

As a recognized clinical and regulatory subject‑matter expert, the Principal Scientist will lead the development of IVDR‑aligned clinical study designs, performance evaluation strategies, and post‑market clinical follow‑up (PMCF/PMPF) activities across the product lifecycle. This role serves as the primary point of accountability for clinical performance under IVDR, ensuring that clinical evidence is scientifically robust, audit‑ready, and aligned with notified body and competent authority expectations.

The Principal Scientist will partner closely with Regulatory Affairs, Quality, R&D, Medical Affairs, and external stakeholders to translate regulatory requirements into executable clinical strategies, drive timely milestone achievement, and proactively mitigate regulatory and compliance risk. Operating with a high degree of autonomy and influence, this role shapes clinical evidence approaches for both new product development and lifecycle sustainment while strengthening Leica Biosystems’ IVDR readiness and long‑term compliance.

In this role, you will have the opportunity to:

• Develop designs of clinical studies to support regulatory submissions (FDA 510(k), PMA, CE-IVDR) for Immunohistochemistry (IHC) & In Situ Hybridization (ISH), Companion Diagnostics (CDx) and Medical Device, ensuring compliance with Good Clinical Practice (GCP), ISO standards, and applicable regulatory requirements.
• Serve as a clinical and scientific liaison with regulatory agencies, key opinion leaders, and external clinical sites, providing expert guidance through creation of study protocols, clinical claims, and evidence generation strategies.
• Author and review critical regulatory documents including clinical study reports, technical files, and scientific publications to support product clearance, approval, and commercialization.
• Establish and maintain strong collaborative relationships with internal cross-functional teams (e.g., R&D, Regulatory Affairs, Medical Affairs, Quality Assurance, Data Management, Clinical Operations, Commercial) and external partners (e.g., CROs, investigators, key opinion leaders) to ensure successful clinical program execution.
• Support and mentor junior clinical scientists and contribute technical expertise to cross-functional teams, while staying informed on relevant regulatory expectations, clinical guidelines, and emerging diagnostic technologies in the IVD space.

The essential requirements of the job include:

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8 plus years of experience in clinical research, specifically with significant experience in US and/or EU trials, or a Master’s degree with 6+ years of experience or Doctoral degree with 3+ years of same experience.
• In-depth understanding of clinical study design and methodology 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 communication (written and verbal) and interpersonal skills for collaborating with cross-functional stakeholders.

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

• Experience in study designs for diagnostic technologies (IVD) is highly preferred, specifically for Immunohistochemistry (IHC) & Companion Diagnostics (CDx).
• Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
• Professional certification in Clinical Research (e.g., SoCRA, ACRP).

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.