Exelixis

Director

• Design, plan, and develop early- and/or late-phase clinical oncology studies
• Prepare and author clinical development documents, including study synopses and protocols
• Summarize study results for documents and publications
• Provide scientific information and progress updates to project teams
• Design, prepare, and initiate study protocols and required documentation in compliance with project plans, federal regulations, GCP, and good medical practice
• Interact with oncology investigators and thought leaders to facilitate clinical synopses and protocols
• Research and assist in selecting investigators for clinical studies
• Conduct literature research for assigned clinical product candidates
• Develop Informed Consent Forms, Case Report Forms, and CRF instructions
• Support medical monitor inquiries with guidance and oversight
• Develop agendas, training materials, and presentations for site visits and investigator meetings
• Participate in internal safety meetings and analyze and report potential safety events
• Review and interpret study data for health authority reports, regulatory filings, and study close-out reports
• Write and/or review product-specific abstracts and publications and support scientific meeting presentations
• Provide feedback on emerging clinical and competitive trends
• Coordinate and facilitate clinical oncology studies while maintaining relationships with investigators
• Deliver scientific presentations on Exelixis investigational agents to physicians and external customers
• Provide clinical education support for internal Exelixis customers
• Maintain clinical and technical expertise in oncology

Clinical Science Director – Biotech Oncology

Compliance

• Provide compliance oversight for the Global Patient Safety and Regulatory Affairs functions, primarily Regulatory Affairs
• Monitor, assess and communicate performance against compliance indicators, metrics and inspection-readiness standards
• Lead compliance monitoring activities and identify compliance and operational risks
• Advance process standardization, consistency and continuous improvement initiatives
• Monitor SmPC updates for commercially sourced products in Exelixis-sponsored studies
• Maintain accurate Reference Safety Information trackers, including health authority submission dates and approvals
• Track partner IB receipt and timely health authority submissions across programs
• Track RFIs to completion within SOP timelines
• Monitor aggregate report compliance to health authorities and CROs
• Ensure Regulatory Affairs documents in the Trial Master File and Veeva RIM remain current and complete
• Monitor Regulatory Affairs training compliance via LMS
• Oversee timely and accurate Regulatory Affairs SOP updates
• Maintain current Regulatory Affairs points of contact for each study with health authorities
• Support the Regulatory Affairs Strategy Team on development programs
• Analyze compliance metrics and contribute to leadership dashboards and slide decks
• Support investigation, tracking and closure of Quality Events, including root cause analysis and CAPAs
• Collaborate with SMEs on deviation assessment and documentation
• Coordinate impact assessments for new and evolving regulations and support implementation plans
• Support health authority inspections and continuous inspection readiness
• Author, review and maintain Regulatory Affairs procedures and standards
• Maintain training matrices and align training requirements with procedural and regulatory expectations
• Identify and conduct quality-related training for Regulatory Affairs team members
• Perform other duties as assigned
• Comply with all policies and standards

Associate Regulatory Affairs Director – Quality, Standards & Training

• Design, plan, and develop early- and/or late-phase clinical oncology studies
• Prepare and author clinical development documents, including study synopses and protocols
• Summarize study results for documents and publications
• Support project teams with scientific information and provide progress updates on assigned studies
• Design, prepare, and initiate study protocols and required documentation in compliance with project plans, federal regulations, GCP, and good medical practice
• Interact with oncology investigators and thought leaders to facilitate clinical synopses and protocols
• Research and assist with investigator selection
• Conduct literature research for assigned clinical product candidates
• Collaborate on Informed Consent Forms, Case Report Forms, and CRF instructions
• Support medical monitor inquiries with guidance and oversight
• Develop agendas, training materials, and presentations for site visits and investigator meetings
• Participate in internal safety meetings and analyze and report potential safety events
• Review and interpret study data for health authority reports, regulatory filings, and study close-out reports
• Write and/or review product-specific abstracts and publications and support scientific meeting presentations
• Provide feedback on emerging clinical and competitive trends
• Coordinate and facilitate clinical oncology studies and maintain relationships with investigators
• Deliver scientific presentations on Exelixis investigational agents to physicians and external customers
• Provide clinical education support for internal Exelixis customers
• Maintain clinical and technical oncology expertise

Cloud Engineer

• Support the design and creation of cloud-based products and services for Exelixis
• Define and design the cloud platform, including cloud automation tools and standards, CI/CD pipelines, DevOps tooling, and AWS account provisioning automation
• Redefine interfaces between cloud platform products and application installation and configuration processes
• Guide major initiatives and lead mid- to large-size complex projects
• Lead end-to-end development from ideation through CI/CD, security scanning, and production monitoring
• Identify and implement improvements to processes and development procedures
• Develop and apply complex, long-term project strategies
• Serve as the department's prime technical contact on contracts and projects
• Translate strategy and communicate across organizational levels and functions
• Interact with senior external personnel on significant technical matters
• Document infrastructure and work instructions, including architecture diagrams, runbooks, code commits, and READMEs
• Lead incident response and root cause analysis for high-impact issues
• Ensure maintainability, performance, observability, access control, permissions, and security controls
• Serve as subject matter expert for assigned capabilities
• Mentor and coach junior engineers

Clinical Science Director – Biotech Oncology

Associate Regulatory Affairs Director – Quality, Standards & Training

Clinical Science Director – Biotech Oncology

Senior Staff Engineer – Cloud Platform