Principal Clinical Scientist, Global Trials & Regulation

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

Benefits offered by this job

Bonus eligible

Flexible remote work

Benefits package

Job summary

Danaher Diagnostics is seeking a Principal Clinical Scientist to lead clinical trial strategies for US and EU markets, supporting Beckman Coulter Diagnostics and Life Sciences. Remote base (onsite in Chaska, MN) option, driving regulatory submissions and evidence plans across diagnostic modalities.

You will design studies, liaise with regulators, collaborate cross‑functionally, and author essential documentation while mentoring junior scientists and ensuring compliance with evolving standards.

Qualifications

• Bachelor’s degree in Life Sciences with 9+ years of clinical research experience, or equivalent advanced degree with 4+ years in US/EU trials.
• Experience designing clinical studies and evidence strategies for regulatory submissions (FDA 510(k)/PMA, CE‑IVDR).
• Excellent written/verbal communication and cross‑functional collaboration with R&D, Regulatory, QA and Commercial teams.

Responsibilities

• Design clinical studies and evidence strategies for regulatory submissions across modalities.
• Act as clinical liaison with regulatory bodies, KOLs, and external sites.
• Partner with R&D, Regulatory, Medical Affairs, Quality and Commercial to align clinical programs with product development and market access needs.
• Author and review clinical/regulatory documentation including study reports and technical files.
• Mentor junior scientists and stay current with evolving regulatory standards.

Skills

Clinical study design

Regulatory submissions

Cross-functional collaboration

Scientific communication

Regulatory affairs

Education

Bachelor's degree in Life Sciences

Master's degree

Doctoral degree

Job description

Danaher Diagnostics is seeking a Principal Clinical Scientist to lead clinical trial strategies for US and EU markets, supporting Beckman Coulter Diagnostics and Life Sciences. Remote base (onsite in Chaska, MN) option, driving regulatory submissions and evidence plans across diagnostic modalities.

You will design studies, liaise with regulators, collaborate cross‑functionally, and author essential documentation while mentoring junior scientists and ensuring compliance with evolving standards.