Clinical Research Scientist - REMOTE

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 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 Clinical Research Scientist reporting to the Manager/Senior Manager of Clinical Research or Principal Clinical Research Scientist, designs, develops and writes clinical protocols and reports in support of research and new product development, registration and commercialization of products.

This position is part of the Clinical Affairs and will be a Remote role. The scientist will have the opportunity to 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 cross-functionally with Scientists, Internally, external partners, Government Affairs, Medical and Scientific Affairs on product evidence strategy plan process (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 as well as prepares scientific content of clinical study reports
• Review clinical section and clinical data for regulatory submissions
• Review pertinent literature, prepares white papers/manuscripts, and provides education to Cepheid staff as needed.

The essential requirements of the job include:

• Bachelor's degree with 2+ years of related work experience OR
• Master's 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
• Has experience collaborating with a multidisciplinary team in the development, creation and execution of study protocols

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
• Knowledge of IVDR EU regulations

Physical Demands:

Approximately 10% travel

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Cepheid, a Danaher 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 .

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.

If you've ever wondered what's within you, there's no better time to find out.

#LI-REMOTE

#LI-JW1

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.

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.

If you've ever wondered what's within you, there's no better time to find out.