Clinical IVD Research Scientist - Remote

Company: Cepheid
Location: Miami
Posted on: November 23, 2021

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 Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

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 Clinical Affairs and will be a Remote role. The clinical research scientist will work on advanced, complex projects requiring innovative knowledge in oncology and/or infectious disease molecular diagnostics. This is an exciting opportunity to collaborate cross-functionally 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: Provide scientific support by interpreting results data for performance studies, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
Assess clinical evidence and state of the art in medicine related to the Cepheid products and intended use to demonstrate safety and performance.
Support development and drafting of clinical study protocols and develop and write high-quality clinical plans and reports with minimal direction.
Prepare scientific content of clinical study reports and review clinical section for regulatory submissions
Conduct comprehensive literature searches for product/technology evaluations and write ad hoc reports based on these literature searches towards regulatory submission.

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 within vitro diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, in oncology and/ or infectious disease
Has experience in collaborating with cross-functional team members in the development and, creation of study protocols in clinical procedures

It would be a plus if you also possess previous experience in:
A Masters or Ph.D. in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology
Strong scientific background with a deep understanding of oncology/infectious disease and the molecular diagnostic area

Travel Demands: Approximately 10% of travel

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.

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 applyassistance@danaher.com to request accommodation.

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

Keywords: Cepheid, Miami , Clinical IVD Research Scientist - Remote, Healthcare , Miami, Florida