Senior Scientist, Clinical Research
About The Position
The Senior 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. This position reports to the Director, Clinical Science and is part of Cepheid Clinical Development located in Sunnyvale, California and will be an on-site role. In this role, you will have the opportunity to: Manage strategies for obtaining clinical evidence using the product evidence strategy plan process (PESP) Develop strategies for clinical trials and ensure that activities are conducted in compliance with current applicable regulations, laws and guidance including but not limited to US and EU and global regulation as well as with Cepheid’s policies and procedures. Establish scientific methods for design and implementation of clinical protocols and have oversight for clinical strategy, protocol development and clinical study reports for US and OUS registration studies Prepares scientific content of clinical study reports and review clinical and analytical sections for regulatory submissions to ensure data meets all necessary regulatory standards. Review pertinent literature, prepare white papers/manuscripts, and provide education to Cepheid staff as needed.
Requirements
- Bachelor’s degree in field with 5+ years of related work experience OR Master’s degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience.
- Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, in oncology and/ or infectious disease
- Experience in IVDD/IVDR or MDD/MDR regulations
Nice To Haves
- A Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology
- Strong scientific background with deep understanding of oncology/infectious disease and the molecular diagnostic area
Responsibilities
- Manage strategies for obtaining clinical evidence using the product evidence strategy plan process (PESP)
- Develop strategies for clinical trials and ensure that activities are conducted in compliance with current applicable regulations, laws and guidance including but not limited to US and EU and global regulation as well as with Cepheid’s policies and procedures.
- Establish scientific methods for design and implementation of clinical protocols and have oversight for clinical strategy, protocol development and clinical study reports for US and OUS registration studies
- Prepares scientific content of clinical study reports and review clinical and analytical sections for regulatory submissions to ensure data meets all necessary regulatory standards.
- Review pertinent literature, prepare white papers/manuscripts, and provide education to Cepheid staff as needed.
Benefits
- paid time off
- medical/dental/vision insurance
- 401(k)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
