Principal Clinical Scientist, Neurodegenerative

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🔥 0 minutes ago

🌵 Arizona, California, +14 more states – Remote

🌵 Arizona – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🐊 Florida – Remote 🎰 Nevada – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote 🌪️ Oklahoma – Remote 🌲 Oregon – Remote 🍂 Massachusetts – Remote 🚗 Michigan – Remote ❄️ Minnesota – Remote 🔔 Pennsylvania – Remote 🤠 Texas – Remote ⛷️ Utah – Remote ☕ Washington – Remote

💵 $120k - $130k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Danaher Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Danaher Corporation is a leading global life sciences and diagnostics innovator that develops and supplies instruments, technologies, software, and services to accelerate scientific research, biotechnology development, and clinical diagnostics. The company operates through businesses focused on biotechnology tools, diagnostics platforms, and life sciences products, leveraging the Danaher Business System and an acquisition-driven strategy to scale technologies and support customers across academia, pharmaceutical and biotech companies, and clinical laboratories.

📋 Description

• Develop clinical trial strategies within the US and EU regions for the Danaher Diagnostics Neurodegenerative program • Support Beckman Coulter Diagnostics and Life Sciences operating companies • Design clinical studies and evidence strategies supporting global regulatory submissions, including FDA 510(k)/PMA and CE-IVDR • Serve as a scientific and clinical liaison with regulatory bodies, key opinion leaders, and external sites • Develop protocols, claims, and evidence plans • Partner with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams • Author and review clinical and regulatory documentation, including study reports, technical files, and publications • Build internal and external collaborations • Mentor junior scientists • Maintain expertise in evolving regulatory standards, clinical guidelines, and diagnostic technologies

🎯 Requirements

• 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 Master’s degree with 12+ years of experience; or Doctoral degree with 4+ years of the 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 written and verbal communication and interpersonal skills • Experience in study designs for diagnostic technologies (IVD), specifically for Neurodegenerative Biomarkers, highly preferred • 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