Senior Scientist, Clinical Research

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 System which makes everything possible. The Senior 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 products. This position reports to the Director, Clinical Science and is part of Cepheid Clinical Development located in 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 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 field with 5+ years of related work experience OR Master’s degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related 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: 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 $116,000 - 159,500. 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 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. For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click 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:View phone number on click.appcast.io or View email address on click.appcast.io. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here.