Xenon Pharmaceuticals Inc.

Director

• Manage and oversee development and manufacturing of cGMP small molecule APIs for pre-pivotal and pivotal clinical trials
• Evaluate, recommend and manage qualified CDMOs for API manufacture for clinical trials and commercial use
• Manage API process technology transfer to CDMOs, including process development and establishment of suitable API specifications
• Translate clinical demand forecasts into API manufacturing plans with Supply Chain and CMC Drug Product colleagues
• Author or review core CMC documents/modules and submissions and responses to the FDA and other competent authorities
• Provide strategic oversight and consistency for IND, NDA, MAA and IMPD filings and periodic updates
• Participate in and manage API-related budget proposals and approved project budgets
• Serve as subject matter expert in audits and inspections of API CDMOs with Quality Assurance
• Ensure Company policies are understood and followed by direct reports
• Travel internationally as required
• Perform other duties as assigned
• Report to the Senior Director, CMC, Drug Substance

Associate Director, CMC, Drug Substance

Clinical Research

• Provide statistical support for assigned clinical development programs or trials
• Participate in the development of study protocols
• Develop statistical analysis plans and analysis specifications for programming implementation of statistical analyses
• Provide statistical input into data management and programming deliverables, including data collection tools and analysis datasets
• Develop statistical programs for ad-hoc requests, manuscripts, and presentations
• Provide statistical review of scientific reports and publications
• Collaborate with other functional areas on project deliverables and timelines
• Provide oversight of CRO deliverables to ensure quality and accuracy
• Adhere to company and department SOPs and working practices
• Act in accordance with Company policies, including the Code of Business Conduct and Ethics
• Perform other duties as assigned
• Report to the Director, Biostatistics

Associate Director, CMC, Drug Substance

Senior Biostatistician