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.
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
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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