Principal Scientist, Clinical Research job opportunity at Danaher.



DatePosted 12 Days Ago bot
Danaher Principal Scientist, Clinical Research
Experience: 12-years
Pattern: full-time
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Clinical Research

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loacation Sunnyvale, California, United States, United States Of America
loacation Sunnyvale, Cal..........United States Of America

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.     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 with   in vitro   diagnostic (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 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     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. 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. #LI-LM3 Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here . We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com .

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