Principal Clinical Scientist

Beckman Coulter Diagnostics seeks a Principal Clinical Scientist to lead clinical trial strategies and evidence development for diagnostic products in US and EU markets. The role involves designing clinical studies, managing regulatory submissions, and collaborating across functions to support product clearance and commercialization.

Responsibilities

• Design clinical studies and evidence strategies for global regulatory submissions across multiple diagnostic modalities
• Serve as scientific and clinical liaison with regulatory bodies, key opinion leaders, and external study sites
• Partner with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams on clinical program alignment
• Author and review clinical documentation including study reports, technical files, and regulatory submissions
• Build collaborations, mentor junior scientists, and maintain expertise in regulatory standards and diagnostic technologies

Requirements

• Bachelor's in Life Sciences or related field with 9+ years clinical research experience, or Master's with 12+ years, or Doctorate with 4+ years
• Deep expertise in clinical study design for diagnostics, medical devices, or pharmaceuticals in US and EU markets
• Ability to identify and resolve complex clinical trial conduct and scientific interpretation issues
• Strong written and verbal communication skills with cross-functional stakeholder collaboration experience
• Valid driver's license with acceptable driving record; ability to travel up to 10% within US and EU
• Experience in diagnostic technology (IVD) study designs, particularly hematology and urinalysis, preferred
• Professional certification in clinical research (SoCRA, ACRP) or advanced degree in science/regulatory affairs, a plus

Compensation: $130,000-$150,000 base, eligible for bonus/incentive pay