Jobs at Exelixis

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 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 antibody-based biologics programs from discovery through IND, focusing on oncology, ADCs, and bispecifics. Oversee in vivo efficacy, PK/PD, and early toxicology studies; write nonclinical IND pharmacology sections; manage cross-functional and external collaborations; expand and mentor Pharm/Tox team; handle project planning, resource management, and communication with senior leadership.

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 Director oversees CMC development and manufacturing operations for pharmaceutical projects, ensuring effective execution, risk management, and collaboration with internal and external teams.

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.

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.

Lead commercial strategy, forecasting, and market research for Zanzalintinib. Develop revenue forecasts, competitive and treatment landscapes, interpret clinical data, drive TPP development, manage vendors, and present strategic recommendations to senior leadership across cross-functional teams.

This role oversees customer data management, drives data integration, collaborates cross-functionally, manages contracts for data procurement, and leads projects to optimize data operations.

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.

Lead biostatistics strategy, operations, tools, and personnel for clinical development. Oversee design and analysis of Phase I–IV studies, regulatory interactions, CRO/vendor management, SOPs, budgets, and cross-functional scientific leadership to ensure data integrity, quality, and timely deliverables supporting drug development.

Develop, train, validate, and document ML and LLM-based models on clinical datasets, ensure GxP-compliant data pipelines and QA, build Databricks/AWS-based pipelines, create dashboards, collaborate with cross-functional clinical teams, and contribute to scientific publications.

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.

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.