Xenon Pharmaceuticals Inc.

Supply Chain

• Lead and manage end‑to‑end supply chain strategy and execution across clinical, pre‑commercial, and commercial phases, including launch and post‑launch stabilization.
• Design and implement scalable supply chain models that evolve with program maturity, from early clinical supply through first commercial launches and lifecycle expansion.
• Anticipate and proactively manage risks related to capacity, inventory, timelines, cost, and compliance during phase transitions.
• Lead integrated demand, supply, and inventory planning across clinical and commercial horizons, ensuring alignment with development milestones, launch timing, and evolving demand forecasts.
• Maintain an in‑depth understanding of external manufacturing site capacities, capabilities, and supply risks across the network.
• Maintain and align vendor forecasts with clinical and commercial demand plans, ensuring clear communication of requirements and constraints.
• Establish and mature S&OP or equivalent integrated planning forums, enabling clear visibility to trade‑offs, constraints, and executive decision points.
• Lead scenario planning to evaluate alternative demand and supply assumptions and inform capacity decisions and risk‑mitigation strategies.
• Lead supply chain readiness for key commercialization milestones, including activities such as: late‑stage clinical supply continuity and transition planning, commercial supply chain design and distribution model definition, commercial lot readiness and launch inventory build.
• Ensure supply chain deliverables are aligned with regulatory submissions, labeling, serialization, and market launch requirements.
• Support launch execution and early commercial stabilization, including issue resolution, performance tracking, and continuous improvement.
• Manage relationships with third‑party manufacturers, suppliers, and vendors to ensure timely delivery of materials, components, and finished goods.
• Negotiate and manage performance expectations, capacity commitments, and risk‑mitigation plans with CMOs and key suppliers. Ensure external partners can scale reliably and compliantly to support commercialization timelines and demand ramp‑up.
• Identify and implement opportunities to optimize supply chain processes and drive efficiencies across planning, execution, and partner management.
• Define, implement, and integrate key performance indicators (KPIs) to monitor performance, identify risks, and drive continuous improvement.
• Use data and performance insights to support corrective actions and operational excellence.
• Support the implementation and adoption of an Enterprise Resource Planning (ERP) system, ensuring alignment with supply chain processes and planning needs.
• Partner with IT and cross‑functional stakeholders to ensure data integrity, usability, and scalability of supply chain systems.
• Work closely with Finance to translate supply and demand plans into financial budgets, forecasts, and variance analyses.
• Partner with CMC, Clinical Operations, Quality, Regulatory, Finance, and Program Teams to ensure aligned execution and commercialization readiness.
• May serve as a trusted advisor to senior leadership on supply chain risks, scenarios, capacity trade‑offs, and launch readiness.
• Ensure supply chain activities meet GxP, regulatory, trade compliance, and company policy requirements.
• Lead and manage supply chain support for audits, inspections, and health authority interactions related to commercialization.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies,
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some international travel may be required.
• Other duties as assigned.

Director – Supply Chain

Director

• Partner with functional stakeholders and vendors to build new solutions supporting the Commercial and Medical functions, including integrations between systems and between Xenon and key service providers
• Author, review, and approve applicable SDLC deliverables, and coordinate assurance and other testing activities
• Develop, review, and approve procedures defining System Administration activities
• Collaborate with Xenon’s Architecture Review Board to ensure the system design is consistent with company standards for security, infrastructure, and data architecture
• Manage and execute day-to-day operations and configuration of the Veeva Commercial suite (CRM, Network, OpenData, etc.), and the day-to-day operations and configuration of other Commercial and Medical IT systems (Publications, MedComms, etc.)
• Ensure system administration and configuration, including workflows, metadata, security, reference data, page layouts, and system settings
• Perform user administration and manage licensing across Commercial and Medical IT systems. Support user onboarding, system training, and operational adoption from a system and process perspective
• Collaborate with data stewards to manage master data management activities, including management of HCPs, HCOs, and associated affiliation data
• Collaborate with key stakeholders to develop and maintain roadmaps, continuous improvement initiatives, and system standardization efforts
• Manage vendor/MSP relationships related to IT systems
• Provide technical guidance and support on change control activities
• Ensure ongoing compliance with Xenon procedures including SaaS Release Management, Change Management, Problem Management, etc.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.

Senior Manager/Associate Director, Commercial & Medical Information Systems

Compliance

• Regulatory Information Management (RIM) system expertise
• Submission/registration management
• eCTD & publishing integration
• Lifecycle management
• Metadata & data governance
• Workflow and process configuration
• Maintain processes for regulatory submission document formatting
• Manage contractual relationships and workstreams with external publishing vendors
• Serve as the unblinded regulatory person for the sign-off
• Manage the submission of expedited safety reports (i.e., SUSARs)
• Support regulatory program leads and project teams in creating timelines
• Maintain the Xenon regulatory submission calendar and trackers
• Provide advice from an operation’s perspective
• Communicate current and emerging publishing and reporting regulatory requirements
• Advise on and direct the evaluation, selection, and implementation of technology
• Contributes to the development of SOPs, Work Instructions and training materials
• Develop and maintain document templates
• Act in accordance with Company policies
• Some international travel may be required
• Other duties as assigned

Senior Manager, Regulatory Affairs, Operations

• Lead teams in late-stage process development and scale up, process validation (PPQ) and commercial manufacturing of small molecule drug products.
• Oversee late phase development and manufacturing processes, ensuring compliance with quality and regulatory standards.
• Manage development activities related to late-stage process development and scale up, FMEA analysis, process validation (PPQ) and preparation for commercial launch of small molecules drug products at partner CDMOs and CMO.
• Manage on-going commercial manufacturing and primary packaging of approved small molecule drug products by working with supply chain, quality and regulatory groups. Serve as CMC SME of commercial drug product supply.
• Manage the selection of late-stage and commercial CDMOs while considering capabilities, capacities, redundancy and quality.
• Provide input for drug product stability programs and help select appropriate packaging for clinical development and commercial use.
• Evaluate, recommend, and manage qualified CDMOs for manufacturing drug products for late-stage clinical trials, scale-up, registration, validation and commercial use. Collaborate with Quality Assurance to manage audits and inspections of CDMOs and on manufacturing investigations.
• Author and review core CMC documents/modules and other submissions and responses to FDA and other Competent Authorities, ensuring strategic oversight and consistency for regulatory interactions, including IND/NDA/MAA/IMPD filings and periodic updates.
• Stay informed on pharmaceutical development and manufacturing industry science, regulatory guidelines and competitive trends to provide informed recommendations.
• Develop and propose objectives in alignment with overall company strategies and plans.
• Collaborate with development and commercial partnerships, including ex-US collaborations, to ensure global alignment and integration of strategies.
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some domestic and international travel will be required.
• Other duties as assigned.

Director – Supply Chain

Senior Manager/Associate Director, Commercial & Medical Information Systems

Senior Manager, Regulatory Affairs, Operations

Director, CMC, Drug Product