Remote Principal Clinical Scientist – Diagnostics

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

Job summary

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist to lead clinical trial strategies across US and EU regions, driving regulatory submissions and milestone delivery for diagnostic programs. The role offers remote-based work with onsite options in MN.

You will design studies, ensure regulatory compliance, and guide evidence generation to support product clearance and market access. You will collaborate across R&D, Regulatory, Medical Affairs, and Quality, mentor junior

Qualifications

• Bachelor’s degree with 9+ years of clinical research experience or Master’s with 12+ years or Doctoral with 4+ years in US/EU trials.
• Deep understanding of clinical study design and methods for diagnostics, medical devices, or pharma intended for US/EU markets.
• Proven ability to identify and solve complex issues in clinical trial conduct and scientific interpretation.
• Ability to critically review and interpret clinical data and oversee study protocols/reports.
• Excellent written and verbal communication and interpersonal skills for collaborating with cross-functional stakeholders.

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, key opinion leaders, 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—to support product clearance and commercialization.
• Build strong internal and external collaborations, mentor junior scientists, and maintain expertise in evolving regulatory standards, clinical guidelines, and diagnostic technologies.

Skills

Communication

Cross-functional collaboration

Regulatory understanding

Clinical research

Education

Bachelor’s degree in Life Sciences or related field

Master’s degree in Life Sciences or related field

Doctoral degree in related field

Job description

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist to lead clinical trial strategies across US and EU regions, driving regulatory submissions and milestone delivery for diagnostic programs. The role offers remote-based work with onsite options in MN.

You will design studies, ensure regulatory compliance, and guide evidence generation to support product clearance and market access. You will collaborate across R&D, Regulatory, Medical Affairs, and Quality, mentor junior