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Clinical Affairs Scientist

Company: Agilent Technologies Inc.
Location: Carpinteria
Posted on: November 27, 2022

Job Description:

Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us. Information about Agilent is available at

We are searching for an experienced Clinical Affairs Scientist to work within the field of medical diagnostics including companion diagnostics (CDx). As a Clinical Affairs Scientist, you will be responsible for the scientific content of clinical project deliverables in support of diagnostics development and commercialization efforts. This position requires strong clinical science background to support clinical trial management, regulatory applications, and scientific marketing activities. The ideal candidate will have a strong background in clinical science/research and experience working in pharmaceutical, biomarker, and/or in vitro diagnostic development. The candidate will work directly with pharmaceutical partners, R&D scientists, Clinical Trial Managers/Clinical Research Associates, Quality Assurance, and Regulatory Affairs to assure compliance with internal and external requirements. High work capacity may be required at certain times in high priority projects.

Responsibilities include but are not limited to:
* Generation of scientific content to support clinical projects including study design, data analysis, and authoring of study protocols and reports.

*Designing and developing databases and case report forms.

*Contributing to validation studies, cutoff determination studies, risk analyses, study quality control activities, and instream data monitoring in clinical trials.

*Ensure scientific validity of reported results including statistical analysis, tabulation, and presentation of data.

*Authoring of Clinical Performance information for regulatory submissions and supporting documentation such as Instructions for Use (IFU).

*Preparing, revising, and maintaining standard operating procedures and guidance for the conduct of clinical studies.

*Serve as the clinical science subject matter expert in cross-functional internal meetings as well as meetings with pharmaceutical partners and regulatory bodies.


*Master's Degree or Ph.D. in pharmaceutical, medical or other relevant biological science field, or a Bachelor's Degree with proven experience.
*2+ years of experience in clinical studies for diagnostics, medical devices and/or pharmaceutical products including authoring protocols and reports.

*Knowledge of clinical study design, biostatistics, and Good Clinical Practice.

*Experience working with external partners and/or regulatory bodies including the FDA.

*Knowledge in oncology and/or pathology preferred.

Location is Carpinteria, CA, or Santa Clara, CA.

Agilent Technologies Inc. is an Equal Employment Opportunity and Affirmative Action employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

As a federal contractor and healthcare company committed to protecting the health and safety of our employees, contractors, customers and communities, employees in the U.S., Puerto Rico, and Canada are required to be fully vaccinated against COVID-19, unless an approved exemption has been granted for a medical reason, sincerely held religious belief, or an employee is otherwise exempt under applicable law. Please see job postings for additional information.

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.

Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please see all of our notices for EEO below.

Travel Required

Schedule:Full time


No End Date

Job Function

Keywords: Agilent Technologies Inc., Santa Barbara , Clinical Affairs Scientist, Healthcare , Carpinteria, California

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