Principal Scientist, Clinical Research

Danaher • Sunnyvale, CA

1d • $186,000 - $232,500 • Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid , one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact . You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate , molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business Syste m which makes everything possible. The Principal 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 produ ct s . This position reports to the Director, Clinical Science and is part of Cepheid Clinical Developme nt l ocated i n 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 PESP. Develop strategies for clinical trials for US, EU and/or rest of the world registration studies as determined by business priorities 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 study 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 and ensure clinical 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 with 12+ years of related work experience OR Master’s degree in field with 8+ years of related work experience OR Doctoral degree in field with 3+ years of work experience.
• Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, in oncology and/ or infectious disease

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 PESP.
• Develop strategies for clinical trials for US, EU and/or rest of the world registration studies as determined by business priorities 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 study 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 and ensure clinical data meets all necessary regulatory standards
• Review pertinent literature, prepare white papers/manuscripts, and provide education to Cepheid staff as needed.

Benefits

• 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 Danaher Benefits Info .
• The annual salary range for this role is $186,000 - 232,500. 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. This job is also eligible for bonus/incentive pay.
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal