Senior Clinical Scientist, Diagnostics & Trials (Remote)

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

Benefits offered by this job

Remote-friendly

Bonus eligibility

Healthcare benefits

401(k) plan

Job summary

Beckman Coulter Diagnostics, part of Danaher Diagnostics, seeks a Principal Clinical Scientist to lead clinical trial strategies in the US and EU. You will design studies, ensure regulatory compliance, and drive milestones for critical trials across diagnostic modalities.

You will collaborate across R&D, Regulatory, Medical Affairs, Quality, and Commercial teams, articulating evidence plans and publications to support product clearance and market access.

Qualifications

• Experience designing clinical studies and evidence strategies for global regulatory submissions.
• Proven ability to interact with regulatory bodies and key opinion leaders.
• Ability to align clinical programs with product development and market access needs.
• Strong writing and interpretation of clinical data and reports.
• Excellent written and verbal communication and collaboration skills.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA/CE) for multiple diagnostic modalities.
• Act as scientific/clinical liaison with regulatory bodies and external sites to develop protocols and evidence plans.
• Partner with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align programs with product development.
• Author and review clinical/regulatory documents, study reports, and publications for clearance and commercialization.
• Mentor junior scientists and maintain expertise in evolving regulatory standards and diagnostic technologies.

Skills

Clinical study design

Regulatory submissions

Scientific communication

Cross-functional collaboration

Mentor junior scientists

Regulatory standards knowledge

Education

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

Master’s degree in Science/Regulatory/Clinical Affairs

Doctoral degree in relevant field

Job description

Beckman Coulter Diagnostics, part of Danaher Diagnostics, seeks a Principal Clinical Scientist to lead clinical trial strategies in the US and EU. You will design studies, ensure regulatory compliance, and drive milestones for critical trials across diagnostic modalities.

You will collaborate across R&D, Regulatory, Medical Affairs, Quality, and Commercial teams, articulating evidence plans and publications to support product clearance and market access.