- 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.
- Prepare 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.
- Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, in oncology and/ or infectious disease.
- Experience in IVDD/IVDR or MDD/MDR regulations.
- 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.
- Ability to travel approximately 10% of the time.
- 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.
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Senior Clinical Research Scientist - Sunnyvale, United States - Cepheid
Description
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 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 team and will be hybrid to Sunnyvale, CA. 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 members on the cross functional team.
In this role, you will have the opportunity to:
At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.
The salary range for this role is $103,000 to $142,000. 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. We may ultimately pay more or less than the posted range. 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.
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. 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. 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.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
