Principal Clinical Scientist, Diagnostics Trials (Remote)

Beckman Coulter Diagnostics; Chaska (MN); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Bonus eligible

Job summary

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions, ensuring regulatory compliance and milestone achievement. This role supports Beckman Coulter Diagnostics and Life Sciences within Danaher Diagnostics and offers on-site opportunities in Minnesota or Florida.

The candidate will drive protocols, collaborate with regulatory bodies, and mentor junior scientists while aligning clinical programs with product development and

Qualifications

• Excellent communication (written and verbal) and interpersonal skills for collaborating with cross-functional stakeholders.
• In-depth understanding of clinical study design and methodology in diagnostics, medical device, or pharmaceutical industry for US/EU markets.
• Experience leading clinical trial strategies and partnership with regulatory bodies.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA 510(k)/PMA, CE‑IVDR) across multiple diagnostic modalities.
• Act as a scientific and clinical liaison with regulatory bodies 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.
• Mentor junior scientists and maintain expertise in evolving regulatory standards and diagnostic technologies.

Skills

Communication skills

Clinical research

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences or related field

Master’s degree in related field

Doctoral degree in related field

Job description

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions, ensuring regulatory compliance and milestone achievement. This role supports Beckman Coulter Diagnostics and Life Sciences within Danaher Diagnostics and offers on-site opportunities in Minnesota or Florida.

The candidate will drive protocols, collaborate with regulatory bodies, and mentor junior scientists while aligning clinical programs with product development and