Principal Scientist, Clinical Research

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🕒 May 26

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Danaher Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

🔬 Science

🤝 B2B

Biotechnology • Science • B2B

Danaher Corporation is a leading global life sciences and diagnostics innovator that develops and supplies instruments, technologies, software, and services to accelerate scientific research, biotechnology development, and clinical diagnostics. The company operates through businesses focused on biotechnology tools, diagnostics platforms, and life sciences products, leveraging the Danaher Business System and an acquisition-driven strategy to scale technologies and support customers across academia, pharmaceutical and biotech companies, and clinical laboratories.

📋 Description

• 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.

🎯 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 • 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

🏖️ Benefits

• Professional development opportunities