Senior Clinical Research Scientist

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

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The Senior Clinical Research Scientist reporting to the Director, Clinical Research, develops and independently writes clinical documentation including clinical protocols, clinical study reports and clinical justifications in support of research and new product development, registration and commercialization of products.

This position is part of Clinical Affairs and will be an Onsite Role in Sunnyvale, CA. The senior clinical research scientist will work on advanced, complex projects requiring state of the art knowledge in oncology and/or infectious disease molecular diagnostics. This is an exciting opportunity to collaborate with other Cepheid scientists, external partners, Government Affairs, Medical and Scientific Affairs on developing the product evidence strategy plan (PESP).   

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.

The essential requirements of the job include:

• Bachelor’s degree in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology with 5+ years of related work experience OR Master’s degree in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology with 3+ years of related work experience OR Doctoral degree in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology with related work experience.

• Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, in oncology and/ or infectious disease

• Proficiency in Microsoft Office Suite 

It would be a plus if you also possess previous experience in:

• 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

• Preferred experience in IVDD/IVDR or MDD/MDR regulations

Physical Demands:

• Ability to travel up to 10% overnight, domestic and international

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

The salary range for this role is $111,100 – 152,800. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.  This range may be modified in the future.

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