Jobs at Exelixis

Leads statistical programming for pharmaceutical and biotech clinical studies using SAS and R. Develops macros, analysis datasets, statistical outputs, data review tools, and regulatory submission components. Oversees CDISC-compliant SDTM and ADaM datasets, CRO deliverables, programming quality control, specifications, and study timelines. Coordinates with biostatistics and clinical data management teams, provides technical guidance, supports training, troubleshoots issues, and contributes to departmental infrastructure and standards.

Designs and leads cloud platform products, automation, CI/CD pipelines, DevOps tooling, and AWS account provisioning. Owns infrastructure strategy, delivery, security controls, incident response, documentation, observability, and root cause analysis. Serves as a technical subject matter expert, leads complex initiatives, collaborates cross-functionally, and mentors engineers. Requires advanced AWS and Terraform expertise in highly available production environments.

Designs and develops Exelixis’s cloud platform, including AWS infrastructure, Terraform-based automation, CI/CD pipelines, DevOps tooling, account provisioning, security controls, and production monitoring. Leads complex technical initiatives, establishes platform strategy, advises stakeholders, resolves advanced infrastructure problems, documents systems, improves operational resilience, and mentors engineers. Requires extensive experience in highly available cloud infrastructure and regulated environments.

Senior leader responsible for AI/ML and data science strategy, team development, governance, and innovation within a regulated pharmaceutical environment. Leads analytics products, generative AI workflows, data platforms, MLOps/LLMOps, validation, reproducibility, and audit readiness. Partners with clinical, statistical, IT, and R&D functions to translate complex datasets into drug-development insights and portfolio decisions. Requires executive communication, budget and partnership management, scientific rigor, and strong knowledge of clinical development and regulatory requirements.

Leads DMPK and modeling strategies supporting drug candidates from discovery through development and registration. Oversees ADME studies, PK/PD analysis, translational strategy, regulatory submissions, CRO activities, and cross-functional collaboration with clinical, toxicology, CMC, and regulatory teams. Provides scientific leadership, evaluates emerging technologies, supports due diligence, presents findings to stakeholders, and contributes to publications and drug development decisions.

Designs and improves cybersecurity solutions protecting AI infrastructure, cloud applications, data, and enterprise systems. Responsibilities include building AI-assisted development tools, implementing guardrails and security controls, monitoring logs, investigating and responding to incidents, identifying vulnerabilities, and advising internal teams and partners. The role requires advanced AWS, infrastructure-as-code, SDLC, CI/CD, scripting, and cybersecurity expertise, with experience in regulated environments preferred. Occasional travel and on-call availability are required.

Manages cost, inventory, collaboration, COGS, and CMC R&D accrual accounting. Oversees close activities, reconciliations, standard costs, reserves, variance analysis, reporting, process improvements, audits, SOX compliance, and accounting systems. Partners with supply chain, FP&A, alliance management, and technical accounting teams while providing staff training and supporting accounting projects.

Supports analytical development and CMC characterization of biologics, including ADCs, monoclonal antibodies, and bispecifics. Develops and transfers LC-MS, chromatography, electrophoresis, and other analytical methods; performs protein characterization, PTM analysis, peptide mapping, conjugation-site analysis, and product-variant assessment. Reviews GMP testing, investigations, validation documentation, and regulatory submissions. Collaborates with internal teams and external CDMOs, provides technical guidance, and helps maintain advanced biologics characterization capabilities.

Leads operational support for pharmaceutical commercial and trade rebates, including invoice review, processing, contract compliance, and cross-functional coordination. Enhances reporting and workflow efficiency using Alteryx and advanced Excel, analyzes PBM data, supports automation with analytics and IT teams, maintains audit documentation, and manages market access projects. May supervise junior analysts or support staff.

Leads complex biotechnology drug development portfolios spanning discovery, CMC, clinical phases, filings, approvals, and post-approval programs. Develops integrated cross-functional plans, manages timelines, budgets, risks, governance, and contingency strategies. Partners with scientific and project leaders to define product development strategy, facilitate execution, communicate with executives, and improve program-management processes. Requires extensive biotech or pharmaceutical experience and expertise across the full drug development lifecycle.

Leads enterprise GMP Quality Assurance strategy across clinical and commercial operations. Oversees product disposition, regulatory inspection readiness, audits, labeling governance, supplier quality, investigations, CAPAs, risk management, and quality systems alignment. Provides executive leadership, independent quality oversight, talent development, and cross-functional governance while ensuring compliance with global GMP regulations and effective management of external manufacturing and supply networks.

Build foundational AI-enabled applications, prototypes, prompts, tests, documentation, and agentic automations. Translate defined requirements into software components, scripts, integrations, and workflow configurations. Support prompt engineering, retrieval-assisted use cases, API integrations, testing, troubleshooting, documentation, code reviews, and demonstrations. Apply software development lifecycle practices, data privacy, information security, compliance, and responsible AI standards while learning from senior team members.

Leads a portfolio of digital applications supporting pharmaceutical discovery, development, and commercialization. Owns product vision, strategy, roadmaps, requirements, prioritization, lifecycle management, and agile delivery. Partners with business, engineering, architecture, quality, operations, and vendors to deliver secure, compliant, user-centered products. Oversees application stability, regulatory compliance, data and AI practices, quality assurance, KPIs, and continuous improvement while mentoring product team members.

Drafts, negotiates, tracks, and manages contracts supporting research, development, and supply chain functions. The role identifies and communicates contractual risks, troubleshoots agreements, advises internal stakeholders, supports in-house attorneys, and handles miscellaneous legal tasks under supervision. It requires strong contract-management, organization, prioritization, communication, and multitasking skills, with biotechnology, pharmaceutical, or high-tech in-house contracting experience preferred.

Leads biostatistical strategy, design, conduct, and analysis for Phase I–IV clinical trials, with emphasis on regulatory compliance and oncology studies. Reviews protocols, case report forms, and statistical analysis plans; interprets results; and supports clinical reports, publications, and integrated safety and efficacy summaries. Provides FDA and EU regulatory guidance, develops department standards, oversees CROs and vendors, and manages deliverables, budgets, and timelines across a therapeutic area.

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 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.

Leads in vivo pharmacology research for oncology drug discovery and development, designing and interpreting PK, PD, efficacy, and toxicity studies in rodent tumor models. Represents Pharmacology on project teams, coordinates CRO studies, prepares study reports and IND filing materials, supports animal facility operations, and ensures IACUC and animal welfare compliance. The role may supervise a small team and requires advanced expertise in tumor models, experimental design, data analysis, cell culture, animal procedures, and pharmacology laboratory software.

Lead strategy, architecture, delivery, and operations of enterprise AI platforms and AI-enabled solutions. Define roadmap, build reusable AI capabilities, deliver production-grade generative and agentic AI, establish AI-native engineering practices, ensure responsible AI governance, and partner with cross-functional stakeholders to scale AI adoption and measure business impact.