Principal Scientist, Clinical Research - Remote UK

About Leica Biosystems At Danaher Diagnostics, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Role Overview: 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. This position is part of the Danaher Diagnostics, Leica Biosystems organization and will be a remote role.

Key Responsibilities:

• 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.

Essential Requirements:

• 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.

Desirable Qualifications:

• 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).

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow.