Principal Scientist, Clinical Research

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences,diagnosticsand biotechnology? 

AtCepheid,one ofDanaher’s15+ operating companies, our work saves lives—andwe’reall united by a shared commitment to innovate for tangible impact.  

You’llthrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanaher’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’llget 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 theDanaher Business Systemwhich makes everything possible.

ThePrincipal Scientist, Clinical Researchis responsiblefordesigning,developingand independently writing clinical protocols and reports in support of research and new product development,registrationand commercialization of products.

This positionreports to theDirector, Clinical Scienceandis part ofCepheid Clinical DevelopmentlocatedinSunnyvale, Californiaand willbeanon-siterole.

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.

The essential requirements of the job include:

• 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 within vitrodiagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, in oncology and/ or infectious disease

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

Travel, Motor Vehicle Record & Physical/Environment Requirements:if applicable for role

• Approximately 10% travel

It would be a plus if you alsopossesspreviousexperience in:

• AMastersor PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology,Biochemistryand/or Human Physiology

• Strong scientific background with deep understanding of oncology/infectious disease and the molecular diagnostic area

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

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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