Clinical Affairs Scientist

Organization
Agilent Technologies, Inc. US
Job Location
Santa Clara, CA
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 www.agilent.com.
Geo Location: Carpinteria, CA (preferred) or Santa Clara, CA
We are searching for an experienced Clinical Affairs Scientist to work within the exciting field of oncology Companion Diagnostics (CDx). As a Clinical Affairs Scientist, your main responsibilities will be to determine clinical strategy in conjunction with team members, write clinical protocols, analyze data and write reports to support the clinical documentation of Companion Diagnostics (CDx)in the field of tissue-based Cancer Diagnostics. This position requires strong support to regulatory applications and scientific marketing activities. The top candidate will have a strong background in biostatistics and experience working in oncology drug, biomarker or in vitro diagnostic clinical development. The candidate will work directly with pharmaceutical partners,clinical and R&D scientists, Clinical Trial Managers and regulatory affairs to assure compliance with internal and external requirements. 
The successful candidate will be measured on:
Your ability to contribute to the clinical strategy for CDx products.
Your professional interactions and communication skills with pharmaceutical partners and regulatory bodies, such as the FDA.
Your ability to work in a fast moving self-driven team.
Your ability to write and interpret clinical protocols, reports and provide data analysis.
Your ability to provide leadership and direction to the clinical affairs scientific staff. 

Requirements: 
University degree in pharmaceutical, medical or other relevant biological science, preferably, advanced degree or equivalent work experience. 
• Typically 4-5 years experience in clinical studies for diagnostic, medical device or pharmaceutical products, including authoring protocols and reports.
• A solid knowledge of clinical study design, biostatistics and Good Clinical Practice.
• Knowledge of oncology and/or pathology is preferred.
• Experience in working in parallel projects teams. 
• High work capacity may be required at certain times in high priority projects.
• Experience from working with external international partners.
• Advanced skills in both written and spoken communication. 
Geo Location: Carpinteria, CA (preferred) or Santa Clara, CA
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.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster available here:
https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf,
https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Suppleme...
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 contact +1-262-754-5030 (US and Canada only) or email job_posting@agilent.com. EOE AA M/F/Vet/Disability  

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