Clinical Affairs Scientist
This position can be performed at our Santa Clara or Carpinteria, CA location. It's a hybrid position allowing you to work from home two days a week.
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 www.agilent.com.
We are searching for an experienced Clinical Affairs Scientist to work within the exciting diagnostic field; including Companion Diagnostics (CDx). As a Clinical Affairs Scientist, your main responsibilities will be to resolve clinical strategy in conjunction with team members to support documentation of diagnostics/CDx in the field of oncology. 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 clinical 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 content to support clinical projects including study design, and authoring of study protocols and reports.
*Designing and developing databases and case report forms.
*Contributing to validation studies, cutoff/cutpoint 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 relevant experience.
*2+ years of experience in clinical studies for diagnostic, medical device and/or pharmaceutical products including authoring protocols, supporting documents, 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.
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.