Jobs in Alameda, CA

About the role

The Associate External Data Management Director is responsible for managing the processing of external and/or local lab data received by Exelixis throughout the clinical trial lifecycle. They provide subject matter expertise in external data handling of various external data sources (ie: central laboratories, pharmacokinetic, immunogenicity, pharmacogenetic and biomarker samples, etc.) to internal cross-functional teams and external stakeholders to ensure high quality data. They provide support to the Lead Data Manager (LDM), Clinical Operations as well as the Biosamples managment group with the review, maintenance, and management of external vendor. Leads functional service provider resources in a matrixed environment.

What you'll bring

• BS/BA degree in related discipline and a minimum of 11 years of related experience
• MS/MA degree in related discipline and a minimum of 9 years of related experience
• Familiarity with oncology laboratory terminology and genomic biomarker and pharmacokinetic/pharmacodynamic endpoints derived from tissue and blood samples is essential.
• A minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials.
• A minimum of 4 years in a project leadership role.
• At least 5 years of experience sFTP and Data Transfer Automation.
• At least 5 years of experience Vendor Management.
• Extensive clinical trial management experience from study initiation through to closeout, with expertise in oncology and/or precision medicine early-phase drug development.
• Experience with Electronic Data Capture (EDC) is required.
• The ability to problem solve and have people/project leadership skills.
• Knowledge of GCP is essential.
• General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDC) systems required.

Benefits