
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.
🕒 August 24
🏄 California, Colorado, +13 more states – Remote
💵 $120k - $130k / year
⏰ Full Time
🔴 Lead
🧪 Clinical Research
🦅 H1B Visa Sponsor
👻 Ghost score 17%
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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.
• Design clinical studies and evidence strategies supporting global regulatory submissions, including FDA 510(k)/PMA and CE-IVDR • Act as a scientific and clinical liaison with regulatory bodies, key opinion leaders, and external sites to develop protocols, claims, and evidence plans • Partner 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 internal and external collaborations • Mentor junior scientists • Maintain expertise in evolving regulatory standards, clinical guidelines, and diagnostic technologies • Lead clinical trial strategies within the US and EU regions for the Neurodegenerative program supporting Beckman Coulter Diagnostics and Life Sciences
• 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 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 for collaborating with cross-functional stakeholders • 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)
• 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
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