Principal Clinical Scientist
$120,000–$165,000 year
On-siteMiami, Florida, United States or Chaska, Minnesota, United States
Job Summary
Design clinical studies and evidence strategies supporting global regulatory submissions across multiple diagnostic modalities for US and EU markets. 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 and diagnostic technologies. This role drives strategic study designs, ensuring regulatory compliance and achieving key milestones for critical clinical studies within the Beckman Coulter Diagnostics and Life Sciences organizations.
Required Qualifications
- Bachelor's degree in Life Sciences, Healthcare, or a related field
- 9+ years of experience in clinical research
- 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
- 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)
- Experience 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)
- Master's degree
- 12+ years of experience
- Doctoral degree
- 4+ years of experience
- located on-site at either Chaska, MN or Miami, FL
- This position is eligible for a remote work arrangement in which you can work remotely from your home
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