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Thermo Fisher Scientific Staff Scientist, Clinical in South San Francisco, California

How will you make an impact?

The Genetic Testing Solutions is seeking an experienced and highly motivated Clinical Study Scientist to work on a team validating qPCR based microbial detection applications for regulated markets. The candidate will have a strong understanding of regulated product development (CE-IVD or US IVD) and QSR systems, a broad understanding of molecular biology and/or biotechnology, strong writing skills, and the ability to collaborate effectively as part of a cross functional team including R&D, Clinical Affairs, Regulatory Affairs, Product Managers, and external partners

What will you do?

  • Design clinical evaluation studies and write protocols and reports required for regulated products

  • Develop plans and process documentation to establish clinical trial sites, and prepare training materials and conduct technical trainings for the clinical trial sites

  • Work with clinical sites, Clinical Affairs, or CRO’s to review and troubleshoot data and ensure compliance with study protocols. Perform study data analysis for the report.

  • During product development phases, evaluate product performance required to support clinical studies

  • Provide technical guidance during interactions with US FDA and other regulatory bodies

  • Supervise team members when necessary

How will you get here?

  • BA/BS Degree, 7+ years/ MS Degree, 5+ years/ PhD Degree, 3+ years of industry experience in Clinical Research, Research & Development, or related job in Medical Device or Pharmaceutical industries.

Experience

  • Strong experience in qPCR and other IVD Diagnostic tests; direct experience with IVD product clinical evaluation studies preferred

  • Understanding product design, development and commercialization for molecular diagnostic products

  • Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics

  • Understanding of Quality Systems Regulations and GCP procedures

Knowledge, Skills, Abilities

  • Proven expertise in clinical study design, data analysis and ability to interpret and summarize scientific results in a clear and accurate manner

  • Good writing skills, excellent time management skills, and ability to work independently required

  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple programs/studies and coordinate with multiple internal and external teams

  • Driven to deliver quality results on time and in a highly ethical and professional manner

  • Demonstrated resourcefulness, strategic and analytical thinking, and directed toward achieving objective

  • Must be tolerant to change, ready to take on new challenges and open to learning new skills

EVRD2020 GTSDouble

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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