Principal Clinical Scientist
Danaher · Chaska, MN +16 more
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Role summary
This Principal Clinical Scientist role leads clinical trial strategies for Danaher Diagnostics across US and EU markets, supporting Beckman Coulter's diagnostic and life sciences divisions. The position involves designing clinical studies, managing regulatory submissions, collaborating with cross-functional teams, and authoring regulatory documentation to support product clearance. Requires a life sciences degree with 9+ years of clinical research experience, particularly in diagnostics or medical devices for regulated markets.
What they're looking for
- Bachelor's degree in Life Sciences or Healthcare with 9+ years clinical research experience
- Master's degree with 12+ years clinical research experience, or Doctoral degree with 4+ years
- In-depth knowledge of clinical study design in diagnostics, medical devices, or pharmaceuticals
- Ability to identify and resolve complex clinical trial conduct issues
- Critical skills reviewing scientific data and overseeing study protocols
- Strong written and verbal communication for cross-functional collaboration
What you'll be doing
- Design clinical studies and evidence strategies for FDA and EU regulatory submissions
- Serve as scientific liaison with regulatory bodies, opinion leaders, and external research sites
- Coordinate with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams
- Author and review clinical documentation including study reports and technical files
- Build collaborations, mentor junior scientists, and maintain regulatory expertise
Privacy & handoff
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