Clinical Affairs Scientist
About the Job
Be a part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to labs, partners and patients globally
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.
In the Companion Diagnostics Business (CDx), our team partners very closely with leading pharmaceutical companies to develop, manufacture and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients.
Become a part of a growing and dedicated team that does truly inspiring work in the field of Precision Medicine. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer.
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.
Responsibilities include but are not limited to:
- Contribute to the clinical strategy for CDx products.
- Interact and communication with pharmaceutical partners, both domestic and international
- Regulary interact with regulatory bodies, such as the FDA
- Write and interpret clinical protocols, reports and provide data analysis
- Provide leadership and direction to the clinical affairs scientific staff
- High work capacity may be required at certain times in high priority projects
Responsible for scientific content of medical and clinical project deliverables, including scientific design and authoring of study protocols and reports. Develops and designs database and Data Report Forms. Contributes with cut-off determination, risk analysis, study quality control and surveillance analysis in clinical trials. Responsible for the scientific validity of reported results and statistical analysis, tabulation and presentation of data. Authors Clinical Investigations section in Premarket Approval Applications, specific sections in Instructions for Use (IFU) and authors Performance testing Clinical section in 510(k) submissions. Prepares, revises and maintains procedures for the conduct of studies.
* Determines and develops approaches to assignments
* Leads clinical projects requiring coordination with other functions, third parties
* Solves a broad range of problems of varying scope and complexity