Jobs at Exelixis

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.

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

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

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

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.

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.

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.

Build and test AI-enabled prototypes, internal tools, prompts, and agentic automations. Translate requirements into small software components, write basic unit tests, support prompt engineering and API integrations, document designs and runbooks, participate in code reviews and demos, and follow data privacy, security, and responsible AI practices while learning SDLC and team processes.

Serve as the primary FP&A business partner to Pharmaceutical Operations & Supply Chain (PSC). Build bottoms-up forecasts, own CMC financial planning, support monthly close and accruals, provide CAPEX and clinical trial forecasting support, drive financial discipline and training across PSC, and deliver strategic analyses and ad hoc projects to align operations with corporate targets.

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.

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 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.