Principal Scientist, Clinical Research

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciencesdiagnosticsand biotechnology

AtCepheidone ofDanahers15 operating companies our work saves livesandwereall united by a shared commitment to innovate for tangible impact.

Youllthrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanahers 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 fastaccurate molecular diagnostic systems and tests. As a member of our teamyoullget 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 worlds most complex health challenges. Together we bring MORE change to the world.

Learn about theDanaher Business Systemwhich makes everything possible.

ThePrincipal Scientist Clinical Researchis responsiblefordesigningdevelopingand independently writing clinical protocols and reports in support of research and new product developmentregistrationand 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 Cepheids 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:

• Bachelors degree with 12 years of related work experience OR

• Masters 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 BiologyBiochemistryand/or Human Physiology

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

Cepheida Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whetheritsa 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 $186000 - 232500. 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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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