Principal Clinical Scientist, Neurodegenerative

This is a fully remote position, open to applicants in Arizona, +15 more states.

📋 Description

• Formulate clinical trial strategies for the Danaher Diagnostics Neurodegenerative program across the US and EU regions.

• Provide support to Beckman Coulter Diagnostics and Life Sciences operating companies.

• Develop clinical studies and evidence strategies that facilitate global regulatory submissions, including FDA 510(k)/PMA and CE-IVDR.

• Act as a scientific and clinical liaison with regulatory authorities, key opinion leaders, and external sites.

• Create protocols, claims, and evidence plans.

• Collaborate with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams.

• Write and review clinical and regulatory documentation, such as study reports, technical files, and publications.

• Foster internal and external partnerships.

• Mentor junior scientists.

• Stay updated on evolving regulatory standards, clinical guidelines, and diagnostic technologies.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Healthcare, or a related field, with over 9 years of experience in clinical research, particularly in US and/or EU trials; or a Master’s degree with more than 12 years of experience; or a Doctoral degree with at least 4 years of relevant experience.

• Comprehensive understanding of clinical study design and methodology within the diagnostics, medical device, or pharmaceutical sectors, specifically for products aimed at the US and EU markets.

• Proven track record in identifying and resolving complex issues related to clinical trial execution and scientific interpretation.

• Capability to critically assess and interpret scientific and clinical trial data, as well as manage the scientific components of study protocols and reports.

• Exceptional written and verbal communication skills, along with strong interpersonal abilities.

• Experience in study designs for diagnostic technologies (IVD), particularly concerning Neurodegenerative Biomarkers, is highly desirable.

• Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.

• Professional certification in Clinical Research (e.g., SoCRA, ACRP).

🏝️ Benefits

• Health care program.

• Paid time off.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• Bonus/incentive pay.

• Flexible remote working arrangements.

• Remote work from home.