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CDx Clinical Director

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.


Location - Carpinteria, CA (relocation assistance is available) Basic Functions:
- Develop and guide Agilent internal customers and external partnerships with Companion Diagnostic (CDx) clinical strategies that support business development.
- Oversee Clinical Affairs activities in Agilent's CDx business.
-Mentor, direct, and oversee managers of CDx Clinical Affairs who perform day to day management of these groups.
-Keep Senior Director of CA updated on CDx issues, needs, and progress.
- Develop CDx organizational clinical strategies, and implement and monitor the activities.
- Build up an efficient organization that supports clinical studies and clinical operations.
- Ensure CDx clinical quality system meets global regulatory requirements and is maintained to meet current standards and global business expectations. Evaluate current processes & procedures and implement new and necessary improvements and additions. Direct managers of CDx clinical groups to execute these changes in day to day operations.
- Provide leadership over clinical trials for current CDx development and partner programs and strategic guidance on anticipated pre/post market clinical trials including internal product validation studies and marketing studies. - Ensure clinical studies/trials are designed, initiated, approved, monitored and reported according to global regulatory requirements (IRBs, ethics committees, study population, biostats, etc.). - Ensure seamless coordination with internal and external partners to obtain regulatory and partnership approval of studies.
- Build a strong clinical trial external network to support activities as needed.
- Represent Agilent externally and internally as clinical operations leader of CDx clinical group, including to Pharma partners
- Supply clinical trial education and expert guidance to Agilent organization and external partners.
- Participate in the development and maintenance of clinical risk benefit analysis and use risks analyses as required.
-Collaborate with central medical affairs group to ensure any CDx related Post-marketing Complaint investigation has appropriate clinical representation.
- Coordinate within internal business partners to ensure statistical expertise is used to secure optimal study protocols, that protocols meet global regulatory requirements and that professional documentation and reporting are conducted.
-Ensure contracting in place for external labs and consultants.
-Participate in Audits and Inspections
- Drive Agilent functional strategies for Clinical Affairs. Organization:
- Reports to Agilent Senior Director of Clinical Affairs.
- The CDx Clinical Director will have direct reports in Carpinteria and Santa Clara.
- Responsible for Agilent performing CDx clinical development tasks in accordance with diagnostic clinical practice primarily in cancer, but to potentially collaborate and grow into the genomics and broader clinical laboratory space.


 

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