Jobs at Exelixis

The Staff Engineer - DevSecOps is responsible for enhancing cybersecurity practices and tools, responding to incidents, and improving the organization's security posture, primarily in cloud environments.

The role involves overseeing IT platforms, driving product strategy, developing secure solutions, mentoring engineers, and managing compliance, focusing on macOS and mobile device management.

The GCP/GVP QA Director manages GCP/GVP systems, ensures compliance and quality in clinical research, supports audits, develops strategies, and trains staff while maintaining regulatory knowledge.

The Senior Corporate Paralegal manages corporate legal records, assists with SEC filings, compliance procedures, and corporate governance matters, while supporting legal and finance teams.

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.

The Associate GCP/GLP QA Director drives consistency in QA systems for clinical trials, manages metrics, and collaborates with teams on compliance and audit findings, ensuring quality in clinical operations.

The Senior GCP/GVP QA Manager assists in developing QA systems for GCP/GLP operations, supports audits, manages compliance metrics, and trains staff.

The Compliance QA Manager coordinates inspection readiness activities, manages audit preparations, and ensures compliance with regulatory standards while supporting continuous improvement efforts.

The Biostatistics Director leads statistical strategy for clinical trials, ensuring adherence to regulatory guidelines and managing project timelines and budgets.

Leads the biostatistics function for clinical trials, providing statistical guidance and overseeing department standards while managing multiple projects and teams.

The Associate GPO & Strategic Partner Marketing Director oversees execution of marketing programs, manages contracts and budgets, and collaborates across teams to optimize marketing efforts.

The Senior Scientist II provides preclinical bioanalytical support for biologics, focusing on LCMS-based assays, pharmacokinetic analysis, and collaboration with teams.

The Biostatistics Director leads statistical strategy for clinical trials, oversees design and analysis, ensures regulatory compliance, and manages timelines and budgets for projects.

The role involves advanced engineering support for client technologies, resolving technical issues, collaborating with stakeholders, and ensuring operational excellence. Responsibilities include troubleshooting, implementing solutions, and maintaining documentation.

The Senior DMPK Director leads DMPK strategies for drug candidates, oversees studies, prepares regulatory documents, and collaborates across departments to inform drug development decisions.

Oversees delivery and execution in Pharmaceutical Operations; drives CMC development and manufacturing, ensures alignment with strategic objectives, and fosters collaboration across teams and partners.

The Biostatistics Director leads statistical analysis and clinical trial design, collaborates with teams, manages CROs, and oversees statistical outputs for clinical trials, especially in oncology.

The role involves strategic planning and commercial analysis for Zanzalintinib, focusing on revenue forecasting, market research, and competitive intelligence, while ensuring collaboration across various functions.