At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible.

The Senior Clinical Research Scientist reporting to the Manager/Senior Manager/Director of Clinical Research or Principal Clinical Research Scientist, develops and independently writes clinical documentation including clinical protocols, clinical study reports and clinical justifications in support of research and new product development, registration and commercialization of products.

This position is part of Clinical Affairs and will be an Onsite Role. The senior clinical research scientist will work on advanced, complex projects requiring state of the art knowledge in oncology and/or infectious disease molecular diagnostics. This is an exciting opportunity to collaborate with other Cepheid scientists, external partners, Government Affairs, Medical and Scientific Affairs on developing the product evidence strategy plan (PESP).  

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 diseaseExperience in IVDD/IVDR or MDD/MDR regulationsFluent in English (written and spoken)Good communication skillsGood ability to structure, organize and prioritize work.

Travel, Motor Vehicle Record & Physical/Environment Requirements

Up to 10% travel each year

It would be a plus if you also possess previous experience in:

A master’s or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human PhysiologyStrong scientific background with deep understanding of oncology/infectious disease and the molecular diagnostic areaFluent in Swedish (written and spoken)

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 danaherbenefitsinfo.com.

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.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.