Senior Clinical Research Scientist
Senior Clinical Research Scientist
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$ 111100 - 152800
1 Vacancy
Job 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 worlds 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 were working at the pace of change on diagnostic tools that address the worlds 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 Director Clinical Research 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 in 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 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 Cepheids 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:
Bachelors degree in Clinical Sciences Health/Life Sciences Molecular Biology Biochemistry and/or Human Physiology with 5 years of related work experience OR Masters degree in Clinical Sciences Health/Life Sciences Molecular Biology Biochemistry and/or Human Physiology with 3 years of related work experience OR Doctoral degree in Clinical Sciences Health/Life Sciences Molecular Biology Biochemistry and/or Human Physiology with related work experience.
Experience with in vitro diagnostic (IVD) products preferably in molecular diagnostics or immunodiagnostics in oncology and/ or infectious disease
Proficiency in Microsoft Office Suite
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
Preferred experience in IVDD/IVDR or MDD/MDR regulations
Physical Demands:
Ability to travel up to 10% overnight domestic and international
Cepheid a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at .
The salary range for this role is $. 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.
Join our winning team today. Together well accelerate the real-life impact of tomorrows 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. 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.
Required Experience:
Senior IC
Employment Type
Full-Time
