[Hiring] Principal Scientist, Clinical Research @Danaher Corporation

Role Description

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.

• 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.
• Serve 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.
• 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.
• Shape 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.

Qualifications

• 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.

Requirements

• 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).

Benefits

• Opportunity to make an immediate, measurable impact on a global scale.
• Environment that fosters career growth and development.