Teams at Exelixis

Designs and executes biostatistical components for clinical research projects. Authors statistical analysis plans, TLF shells, and ADaM/SDTM specifications; reviews CRFs and endpoints; performs data analysis and interpretation; collaborates with clinical teams, CROs, and regulatory stakeholders to produce reports and ensure compliance with FDA/EMA guidance.

Lead GxP inspection readiness and regulatory inspection management, direct internal audits and mock inspections, oversee CAPA closure, and provide cross-functional compliance guidance. Develop and execute inspection readiness strategy, manage auditor relationships and supplier/vendor audits, and support global regulatory inspection activities and responses to health authority findings.

The Senior Corporate Counsel drafts and negotiates contracts, overseeing legal aspects of R&D transactions, while managing risks and guiding junior attorneys.