Jobs 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.

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

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

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 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.

Lead a portfolio of digital products for pharmaceutical R&D, clinical, and commercial functions. Define strategy and roadmaps, lead agile product teams, manage vendors, ensure GxP/HIPAA/GDPR compliance, drive product delivery and operational stability, and track KPIs to optimize adoption and business value.

Lead design and implementation of cloud security architectures, investigate and remediate security incidents, integrate security tooling into CI/CD pipelines, assess vulnerabilities, collaborate cross-functionally, and ensure regulatory compliance (SOX, FDA) while improving organizational security posture.

Lead development and execution of US promotional tactics for Cabozantinib in RCC, aligning messaging with brand objectives. Manage promotional budget, vendor/agency relationships, cross-functional collaboration (sales, medical, regulatory), and measure campaign performance while ensuring FDA and compliance adherence.

The Associate Principal Architect will design and implement cloud-based data architectures on AWS and Databricks, manage data governance, and lead CI/CD pipelines, optimizing for security and performance in advanced analytics settings.

Design and evolve a cloud analytics platform: define automation, IaC, CI/CD, and governance; lead complex projects; mentor engineers; ensure compliance and platform reliability for regulated biotech environments.

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.

Lead and manage biostatistics for early-phase oncology programs, providing statistical strategy, trial design and analysis, biomarker and translational medicine guidance, regulatory interaction, vendor/CRO oversight, team recruitment/development, and department standards/process improvements to ensure successful clinical development.

Lead QA support for quality systems (Deviations, Change Control, CAPA) and Veeva enhancements; oversee clinical and commercial artwork and labeling reviews, vendor oversight, risk-based GxP strategy, metrics and continuous improvement, and inspection/audit readiness while partnering cross-functionally to resolve quality issues and drive timely, compliant record closure.

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

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.