Principal Scientist, Clinical Research

Cepheid

Sunnyvale, California, United States
$186,000 - 232,500; bonus/incentive pyy eligible; ...
Clinical protocol design
Clinical trial strategy development
Regulatory submission review
The Principal Scientist, Clinical Research is responsible for designing, developing and independently writing clinical protocols and reports in support of research and new product development, registration and commercialization of products

Job Summary

  • The Principal Scientist, Clinical Research is responsible for designing, developing and independently writing clinical protocols and reports in support of research and new product development, registration and commercialization of products.
  • Develop strategies for clinical trials for US, EU and/or rest of the world registration studies as determined by business priorities and ensure that activities are conducted in compliance with current applicable regulations, laws and guidance.
  • Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.

Matching Summary

The Principal Scientist, Clinical Research is responsible for designing, developing and independently writing clinical protocols and reports in support of research and new product development, registration and commercialization of products.

Salary

$186,000 - 232,500; Bonus/Incentive pay eligible; Comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k)

Skills & Requirements

Must-have

  • Clinical protocol design
  • Clinical trial strategy development
  • Regulatory submission review
  • In vitro diagnostic (IVD) products
  • Molecular diagnostics or immunodiagnostics

Nice-to-have

  • Continuous improvement culture
  • Career growth and development
  • Scientific literature review
  • White paper preparation
  • Education to staff

Key Requirements

  • Bachelor’s degree with 12+ years of related work experience
  • Master’s degree in field with 8+ years of related work experience
  • Doctoral degree in field with 3+ years of work experience
  • Experience with IVDD/IVDR or MDD/MDR regulations
  • Approximately 10% travel

Work Rights

Not specified

Tailored Resume

Cover Letter