Jobs at Exelixis

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 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.

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

Build and prototype agent-based AI applications and workflows, connecting LLMs, prompts, tools, and APIs. Rapidly prototype then harden code, execute CI/CD and testing, write docs/runbooks, participate in reviews, and apply secure-by-design and responsible AI practices.

Design, build, and deploy production-grade agentic applications and multi-agent workflows that automate IT and business processes. Convert prototypes into hardened services, integrate LLMs and enterprise data sources, implement CI/CD and observability, author runbooks and docs, lead reviews and threat modeling, and apply secure-by-design and responsible AI practices.

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.

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.

Provide contracting support for IT, information security, privacy, and other G&A functions. Draft, negotiate, manage vendor agreements, advise on risks, improve contracting processes, and develop templates/playbooks.

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

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.

Lead complex sourcing and outsourcing initiatives for G&A, IT, and Commercial categories in pharma/biotech. Partner with stakeholders to drive cost savings, contract negotiation, supplier performance, risk mitigation, and process improvements. Mentor junior staff, manage SOWs and vendor governance, and support compliance and audit readiness.

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.

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

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.

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.