Close Menu

Staff Scientist, Clinical Studies

Organization
Thermo Fisher Scientific
Job Location
180 Oyster Point Blvd,
South San Francisco, CA 94080
United States
Job Description

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?

  • Write protocols and reports required for clinical evaluation studies of regulated products

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

  • Develop plans and process documentation that meet IRB requirements to establish clinical trial sites

  • Prepare training materials and conduct technical trainings for the clinical trial sites, and design experiments required to support clinical studies

  • Work with clinical sites, Clinical Affairs, or CRO’s to review and troubleshoot data and ensure compliance with study protocols

  • Supervise team members when necessary

Requirements

Education:

  • 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

  • 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 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


Excellent verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner

About Our Organization

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.