Senior Clinical Scientist, Diagnostics - Remote

Beckman Coulter Diagnostics; Charlotte (NC); Remote; USD 120,000 - 130,000; Full time

Benefits offered by this job

Bonus eligible

Medical/dental/vision insurance

401(k)

Job summary

Beckman Coulter Diagnostics, a Danaher Diagnostics company, seeks a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions. You will design studies, liaise with regulators, and drive evidence plans across diagnostic modalities, influencing product clearance and market access.

The role offers remote flexibility with onsite options in MN, and requires deep experience in US/EU trials, regulatory compliance, and collaboration across R&D, Medical Affairs, and Quality

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or related field with 9+ years of clinical research experience (US/EU).
• Master’s degree with 12+ years of similar experience, or Doctoral degree with 4+ years.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA 510(k)/PMA, CE‑IVDR).
• Serve as scientific/clinical liaison with regulatory bodies, key opinion leaders, and external sites.
• Partner with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align programs with product development and access needs.
• Author and review clinical/regulatory documentation including study reports and publications.
• Mentor junior scientists and maintain expertise in evolving regulatory standards and diagnostic technologies.

Skills

Clinical trial design

Regulatory knowledge

Data interpretation

Cross-functional collaboration

Written and verbal communication

Education

Bachelor’s degree in Life Sciences/Healthcare or related field

Master’s degree in Life Sciences/Healthcare or related field

Doctoral degree in Life Sciences/Regulatory/Clinical Affairs

Job description

Beckman Coulter Diagnostics, a Danaher Diagnostics company, seeks a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions. You will design studies, liaise with regulators, and drive evidence plans across diagnostic modalities, influencing product clearance and market access.

The role offers remote flexibility with onsite options in MN, and requires deep experience in US/EU trials, regulatory compliance, and collaboration across R&D, Medical Affairs, and Quality