Note: The job is a remote job and is open to candidates in USA. Danaher, through its Beckman Coulter Life Sciences division, is dedicated to improving healthcare with innovative diagnostic solutions. The Principal Clinical Scientist will be responsible for leading clinical trial strategies, ensuring regulatory compliance, and collaborating with various teams to drive product development and market access.
Responsibilities
- Design clinical studies and evidence strategies supporting global regulatory submissions (e.g., FDA 510(k)/PMA, CE‑IVDR) across multiple diagnostic modalities
- Act as a scientific and clinical liaison with regulatory bodies, key opinion leaders, and external sites to develop protocols, claims, and evidence plans
- Partner cross‑functionally with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align clinical programs with product development and market access needs
- Author and review clinical and regulatory documentation—including study reports, technical files, and publications—to support product clearance and commercialization
- Build strong internal and external collaborations, mentor junior scientists, and maintain expertise in evolving regulatory standards, clinical guidelines, and diagnostic technologies
Skills
- Bachelor's degree in Life Sciences, Healthcare, or a related field with 9+ years of experience in clinical research, specifically with significant experience in US and/or EU trials, or a Master's degree with 12+ years of experience or Doctoral degree with 4+ 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
- Experience in study designs for diagnostic technologies (IVD) is highly preferred, specifically for Clinical Chemistry, Immunoassays, Hematology, Urinalysis, Flow Cytometry, and/or Biomarkers
- Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs
- Professional certification in Clinical Research (e.g., SoCRA, ACRP)
Benefits
- Bonus/incentive pay
- Paid time off
- Medical/dental/vision insurance
- 401(k) to eligible employees
- Remote work arrangement in which you can work remotely from your home
Company Overview
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