Lead Clinical Scientist, Diagnostics (Remote)

Beckman Coulter Diagnostics; Tulsa (OK); Remote; USD 120,000 - 130,000; Full time

Benefits offered by this job

Bonus eligible

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist who will lead clinical trial design and evidence strategies to support global regulatory submissions. You will liaise with regulatory bodies and external sites, guiding protocols and evidence plans while collaborating with R&D, Regulatory, Medical Affairs, and Quality teams.

The role requires deep expertise in US/EU trials, strong scientific writing, and the ability to mentor junior scientists, staying current with evolving

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 9+ years of experience in clinical research, specifically with significant experience in US and/or EU trials, or a Master’s degree with 12+ years of experience or Doctoral degree with 4+ years of same experience.
• In-depth understanding of clinical study design and methodology in the diagnostics, medical device, or pharmaceutical industry with products intended for the US and EU markets.
• Demonstrated ability to identify and solve complex issues in clinical trial conduct and scientific interpretation.
• Ability to critically review and interpret scientific and clinical trial data, and oversee the scientific aspects of study protocols and reports.
• Excellent communication (written and verbal) and interpersonal skills for collaborating with cross‑functional stakeholders.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (e.g., 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

Clinical trial design

Regulatory knowledge (FDA/CE)

Scientific communication

Cross-functional collaboration

Regulatory documentation

Education

Bachelor’s degree in Life Sciences

Master’s degree in related field

PhD preferred

Job description

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist who will lead clinical trial design and evidence strategies to support global regulatory submissions. You will liaise with regulatory bodies and external sites, guiding protocols and evidence plans while collaborating with R&D, Regulatory, Medical Affairs, and Quality teams.

The role requires deep expertise in US/EU trials, strong scientific writing, and the ability to mentor junior scientists, staying current with evolving