Senior Clinical Scientist, Diagnostics - Remote

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

Job summary

Beckman Coulter Diagnostics, part of Danaher Diagnostics, is seeking a Principal Clinical Scientist to lead clinical trial strategies for the US and EU. You will design studies, ensure regulatory compliance, and drive milestones for pivotal clinical investigations that support product clearance and market access.

This remote-based role (onsite in Chaska, MN optional) collaborates closely with R&D, Regulatory, Medical Affairs, and Quality teams, mentoring junior scientists while advancing

Qualifications

• Bachelor’s degree in Life Sciences with 9+ years in clinical research or Master’s with 12+ years, or Doctoral with 4+ years of similar experience.
• Experience in US and/or EU clinical trials.
• Understanding of clinical study design and regulatory requirements in diagnostics/pharmaceuticals.

Responsibilities

• Design clinical studies and evidence strategies for global regulatory submissions (FDA 510(k)/PMA, CE‑IVDR).
• Serve as scientific liaison with regulators, key opinion leaders, and external sites.
• Collaborate with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align programs with product development and market access.
• Prepare and review study reports, technical files, and publications for product clearance and commercialization.
• Mentor junior scientists and stay current with evolving regulatory standards and diagnostic technologies.

Skills

Clinical trial design

Regulatory understanding

Scientific interpretation

Communication

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

Doctoral degree in Life Sciences

Job description

Beckman Coulter Diagnostics, part of Danaher Diagnostics, is seeking a Principal Clinical Scientist to lead clinical trial strategies for the US and EU. You will design studies, ensure regulatory compliance, and drive milestones for pivotal clinical investigations that support product clearance and market access.

This remote-based role (onsite in Chaska, MN optional) collaborates closely with R&D, Regulatory, Medical Affairs, and Quality teams, mentoring junior scientists while advancing