Principal Scientist, Clinical Research

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Danaher

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

🏥 Healthcare

🔬 Science

Biotechnology • Healthcare • Science

Danaher is a leading global life sciences and diagnostics innovator that applies science and technology to improve human health. Its portfolio includes businesses in biotechnology, diagnostics, and life sciences that provide instruments, tools, software and services to accelerate research, develop and deliver therapies, and enable precise and rapid diagnostics. Danaher emphasizes continuous improvement through its Danaher Business System, pursues acquisitions and partnerships to expand capabilities, and focuses on scaling scientific innovation and delivering impact at global scale.

📋 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, 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.

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development opportunities