Senior Clinical Scientist, Neurodegenerative Diagnostics

Beckman Coulter Diagnostics; Phoenix (AZ); Hybrid; USD 120,000 - 130,000; Full time

Benefits offered by this job

Remote work flexibility

Bonus incentive pay

Benefits package

Job summary

Beckman Coulter Diagnostics seeks a Principal Clinical Scientist to lead clinical trial strategies in the US and EU for the Neurodegenerative program. You will drive study designs, ensure regulatory compliance, and achieve milestones for pivotal studies across diagnostic modalities.

You will serve as scientific liaison with regulators, collaborate with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams, and oversee study protocols and reports for product clearance and market access.

Qualifications

• Bachelor’s degree in Life Sciences with 9+ years of experience in clinical research, especially US/EU trials.
• In-depth understanding of clinical study design and methodology in diagnostics, medical devices, or pharma.
• Strong ability to identify and solve complex issues in clinical trial conduct and interpretation.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA 510(k)/PMA, CE‑IVDR).
• Act as scientific liaison with regulatory bodies, KOLs, and external sites to develop protocols and evidence plans.
• Collaborate cross‑functionally with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align programs with product needs.
• Author and review clinical/regulatory documentation—study reports, technical files, publications.
• Mentor junior scientists and maintain expertise in evolving regulatory standards and diagnostic technologies.

Skills

Clinical research

US/EU trials

Regulatory strategy

Study design

Scientific writing

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Master's degree

Doctoral degree

Job description

Beckman Coulter Diagnostics seeks a Principal Clinical Scientist to lead clinical trial strategies in the US and EU for the Neurodegenerative program. You will drive study designs, ensure regulatory compliance, and achieve milestones for pivotal studies across diagnostic modalities.

You will serve as scientific liaison with regulators, collaborate with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams, and oversee study protocols and reports for product clearance and market access.