Xenon Pharmaceuticals Inc.

Manager

• Lead and manage data management activities for assigned products, initiatives and/or clinical trials
• Design clinical trial databases, including CRF Development, Database Validation, and Data Review tools
• Oversee external data management vendors
• Optimize data management and collection activities
• Maintain current knowledge of relevant issues related to data management
• Propose, draft, and maintain relevant Standard Operating Procedures
• Act in accordance with Company policies

Senior Manager, Data Management

Operations

• Provide clinical trial management leadership for multiple Phase 3 studies, across therapeutic areas.
• Collaborate with cross-functional team members to ensure highly integrated plans and documents for clinical trials.
• Develop, propose, and manage plans for assigned studies and activities.
• Lead the preparation of Requests for Proposals (RFPs) in collaboration with other internal team members.
• Manage contracted service providers to deliver against the contracts.
• Lead the selection of qualified investigators and study sites in collaboration with the Clinical Development team.
• Review and oversee study budgets and invoices to ensure vendors are invoicing in accordance with their contracts.
• Develop and manage study timeline and study metrics cross-functionally.
• Conduct risk assessments, mitigation strategies and contingency planning.
• Communicate with internal/external teams to proactively recognize challenges and work cross-functionally on strategies to mitigate/resolve.
• Actively participate in all aspects of clinical trial operations, including the coordination, writing, review and/or finalization of clinical trial protocols, consent forms, case report forms, study plans, safety reviews and other essential regulatory documents.
• Train and mentor new staff or peer mentorship of new hires.
• Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice.
• Participate in the development and updating of standard operating procedures as required.

Manager – Trial Operations

QA Engineer

• Lead and manage quality oversight of the Company’s GLP programs
• Lead and manage quality oversight of the Company’s early phase clinical programs
• Provide expert GLP/GCP compliance interpretation, consultation, training, root cause analysis, and other supportive services necessary to maintain and improve R&D programs
• Identify and escalate critical quality issues appropriately to QA Management
• Assist with the preparation and coordination of regulatory inspections
• Maintain effective cross-functional communications
• Ensure compliance with relevant legislation and regulations
• Develop and propose short- and long-term objectives for the GLP/GCP functions
• Plan and manage budget proposals and approved budgets
• Recruit, lead, direct, develop, coach and evaluate direct reports
• Act in accordance with Company policies

Director, Quality Assurance, GCP

• Responsible for quality-related matters related to manufacturing, testing and release at a CMO focusing on products in the clinical stage of development
• Lead and support activities related to external quality such as batch reviews and release, analytical method validations, tech transfers, deviations, quality agreements, and supplier qualifications
• Collaborate with internal CMC functions
• Author and review/approve quality documents including quality agreements, dispositions, Quality systems documents, audit reports
• Attend CMO and internal CMC team meetings and provide quality feedback
• Support quality system and product review meetings
• Represent Quality function on project teams, Health Authority Inspections, suppliers and CMO operational meetings
• Promote a quality mindset and quality excellence approach throughout the organization
• Recruit, lead, direct, develop, coach and evaluate direct reports

Director, Quality Assurance – GMP

• Responsible for quality-related matters at a CMO focusing on clinical products
• Lead and support external quality activities like batch reviews and release
• Collaborate with internal CMC functions ensuring cGMP compliance
• Author and review quality documents
• Attend CMO and internal team meetings
• Support quality system and product review meetings
• Represent Quality function on project teams
• Promote a quality mindset throughout the organization
• Recruit, lead, direct, develop, coach and evaluate direct reports
• Act in accordance with Company policies and ensure adherence

Director

• Support the development and execution of medical affairs plans for Xenon’s epilepsy program in alignment with overall medical, clinical development, and commercialization strategies
• Maintain strong understanding of product data, disease state, and evolving clinical landscape to support internal discussions and medical decision making
• Contribute to insight gathering activities and evidence planning to inform medical strategy and launch preparation
• Serve as a key Medical Affairs partner for epilepsy related activities, collaborating with Commercial/Marketing, Market Access, Regulatory, Legal/Compliance, Pharmacovigilance, and other functions as appropriate
• Participate in cross functional forums to ensure scientific alignment and consistent, compliant communication across the development and launch lifecycle
• Review promotional and non promotional materials as a Medical Affairs reviewer to ensure scientific accuracy and compliance with internal and external standards
• Support scientific engagement with healthcare professionals, key opinion leaders, and patient advocacy organizations to gather insights and support medical strategy
• Contribute to advisory boards, investigator interactions, congress activities, and other external scientific exchanges in Epilepsy under appropriate guidance
• Represent Medical Affairs in scientific discussions to advance understanding of Xenon’s research and commitment to patients
• Contribute to the planning and oversight of post marketing studies, real world evidence initiatives, and investigator initiated research in Epilepsy
• Partner with RWE, HEOR, and cross functional colleagues to support evidence generation activities aligned with medical strategy
• Partner with Scientific Communications to support publication planning and development of congress and educational content for Epilepsy
• Review abstracts, manuscripts, and other scientific disclosure materials to ensure accuracy, quality, and compliance
• Support internal training and medical education initiatives related to the epilepsy program
• Perform additional duties as assigned to support Medical Affairs objectives and evolving business needs
• Conduct all activities in accordance with company policies, timelines, and quality standards
• 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

Director, Medical Affairs – Epilepsy

Compliance

• Provide strategic regulatory advice, review, and decisions for product promotion, disease state education, pipeline, and Medical materials for alignment with applicable FDA regulations and guidance documents
• Provide strategic regulatory support to the business by generating innovative solutions and effective problem-solving aligned with the company’s guiding principles in order to achieve desired outcomes
• Develop and establish strong internal cross-functional relationships with the Commercial, Medical Affairs, Legal, Compliance, Corporate Affairs, and Development to foster open communication, collaboration, and teamwork
• Continually monitors and evaluates the regulatory environment, interprets new regulations, guidance documents, enforcement activities and trends for potential impact on the business and company
• Maintain in-depth understanding of clinical trial design and interpretation of clinical data and communicate complex issues clearly and concisely
• Establishes and maintains a relationship with the Office of Prescription Drug Promotion (OPDP) at FDA
• Provide appropriate oversight of promotional material review and ensure on-time and accurate submission of applicable materials to FDA
• Assist with training employees at Xenon and in developing and improving process efficiencies
• 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
• Other duties as assigned

Director, Regulatory Affairs – Commercial, Advertising & Promotion

Data Engineer

• Manage the implementation and maturation of Xenon’s enterprise integration and data engineering capabilities
• Partner with IT and business leaders to define and maintain an enterprise integration roadmap
• In consultation with assigned stakeholders, evaluate, select, implement, and govern integration and ELT platforms
• Design and oversee integrations and data pipelines between internal and external systems
• Establish reusable integration standards, data contracts, interface specifications, transformation patterns, naming conventions, monitoring/alerting practices, runbooks, and documentation standards
• Collaborate with Xenon’s Architecture Review Board to ensure system and data-flow designs are consistent with company standards
• Partner with business data owners and data stewards to establish and maintain effective data governance
• Provide technical leadership for data models, ELT transformations, curated data layers, and “gold” datasets
• Ensure integration and data engineering solutions are designed with appropriate controls for GxP, SOX, HIPAA, GDPR, 21 CFR Part 11, auditability, data integrity, and role-based access
• Provide technical guidance and support for Computer Systems Assurance (CSA), SDLC, regulatory/risk assessment, testing, validation, and change control deliverables
• Develop and manage the ongoing support model for integrations and data pipelines
• Monitor integration and pipeline performance
• Translate business requirements into practical integration architecture, technical design, delivery plans, test strategies, and sustainable operating procedures
• Lead, mentor, or coordinate internal and external data engineers, integration developers, analysts, and vendor resources as the capability grows.

Senior Manager – Enterprise Integration, Data Engineering

• Lead design and management of competitive total rewards strategies for talent retention
• Manage base salary program and incentive compensation for non-sales employees
• Coordinate the design and management of equity programs
• Oversee US benefits management and legal compliance
• Collaborate with HRBPs on career framework evolution
• Conduct compensation surveys participation

Executive Director – Total Rewards

Systems Engineer

• Serve as the technical system owner for the Microsoft 365 platform
• Serve as the technical system owner for Workplace Systems
• Partner with the Infrastructure Team on managing users and devices
• Continuously review Copilot releases and promote adoption
• Develop multi-year roadmaps for Copilot and productivity solutions
• Design, configure, document, deploy, and support collaboration systems
• Function as a technical project lead
• Manage vendors and external resources to maximize return on investment
• Ensure compliance with internal processes and relevant regulations
• Participate in after hours on-call support rotation

Senior Systems Engineer – Microsoft

Human Resources

• Lead and manage and the HR Operations team to ensure end-to-end employee life cycle considerations and activities are executed in accordance with department and program objectives;
• Collaborate with other HR Program Leads and Xenon departments on data requests and cross-functional activities, to support company-wide processes and requirements.
• Collaborate with HR Systems Lead and other HR Program Leads to facilitate and support new and evolving business systems and processes to enable rapid growth and change.
• Develop and maintain relevant policies, procedures and systems relevant to the HR function’s operations team, including for various audit and reporting purposes.
• Oversee a broad range of HR operational activities, including records and documentation, templates and manuals, budget oversight, and team coordination.
• Provide expert counsel to assigned departments in Canada and the US for all HR programs.
• Collaborate with business and science leaders to coach and to ensure HR programs are optimally used by managers and employees.
• Manage all Performance Management program activities related to individual objectives, mid-year review, year-end review, and 360 Feedback process in accordance with the department and company calendar.
• Collaborate with EVP, HR to support the work of the Diversity, Equity, Inclusion and Accessibility Employee Committee.
• Lead and/or support a variety of HR, legal, financial and other assigned projects and requirements.
• Act as a champion for Xenon’s culture and values.
• 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.

Director, Human Resources

• Manage and oversee the development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards.
• Evaluate, recommend, and manage qualified CDMOs for the manufacture of API for clinical trials, as well as for commercial use.
• Serving as the subject matter expert, participate in audits and inspections of API CDMOs in conjunction with Quality Assurance.
• Collaborating closely with the internal process chemistry team, manage API process technology transfer to the Company’s CDMOs, including process validation and the establishment and refinement of suitable specifications for APIs.
• Work closely with Supply Chain and CMC Drug Product colleagues to translate demand forecasts (both clinical and commercial) into API manufacturing plans.
• Author (in conjunction with Technical Writing) and/or act as a key reviewer of core CMC documents/modules and other forms of submissions and responses to FDA and other Competent Authorities providing strategic oversight and consistency for regulatory interactions, including, but not limited to, IND/NDA/MAA/IMPD filings and periodic updates thereto.
• Plan and manage API-related budget proposals and approved project budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports in accordance with the Company’s Human Resource policies and practices.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• 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.

Director, CMC, Drug Substance

• Provide clinical trial management leadership for multiple Phase 1 and 4 studies, across therapeutic areas
• Collaborate with cross-functional team members to ensure integrated plans and documents for clinical trials
• Develop, propose, and manage plans for assigned studies and activities
• Lead preparation of Requests for Proposals (RFPs) in collaboration with internal team members
• Manage contracted service providers to deliver against contracts
• Lead selection of qualified investigators and study sites in collaboration with Clinical Development team
• Review and oversee study budgets and invoices
• Develop and manage study timeline and study metrics cross-functionally
• Conduct risk assessments, mitigation strategies, and contingency planning
• Communicate with internal/external teams to recognize challenges and collaborate on strategies to mitigate/resolve
• Participate in all aspects of clinical trial operations
• Train and mentor new staff or peer mentorship of new hires
• Oversee adherence to applicable regulations
• Participate in development and updating of standard operating procedures
• Act in accordance with Company policies

Senior Manager, Trial Operations

• Provide clinical trial management leadership for multiple Phase 1 and 4 studies, across therapeutic areas
• Collaborate with cross-functional team members to ensure highly integrated plans and documents for clinical trials
• Develop, propose, and manage plans for assigned studies and activities
• Lead the preparation of Requests for Proposals (RFPs) in collaboration with other internal team members
• Manage contracted service providers to deliver against the contracts
• Lead the selection of qualified investigators and study sites
• Review and oversee study budgets and invoices to ensure vendors are invoicing in accordance with their contracts
• Develop and manage study timeline and study metrics cross-functionally
• Conduct risk assessments, mitigation strategies and contingency planning
• Communicate with internal/external teams to proactively recognize challenges
• Actively participate in all aspects of clinical trial operations, including coordination, writing, review and/or finalization of clinical trial protocols and consent forms
• Train and mentor new staff or peer mentorship of new hires
• Oversee adherence to applicable regulations and standards of clinical practice

• Lead the development and execution of U.S. pricing strategy, including launch price recommendations and lifecycle pricing management
• Design and implement payer contracting strategies, including rebate structures and contracting frameworks with pharmacy benefit managers (PBMs), national payer organizations, and regional health plans
• Support contract negotiations and ensure pricing and rebate strategies align with payer coverage objectives
• Lead financial modeling and pricing scenario analyses to evaluate the impact of pricing and contracting strategies on market access, reimbursement, and overall company financial performance
• Develop and manage gross-to-net (GTN) models that support financial forecasting, access strategy decisions, and pricing scenario planning
• Collaborate closely with Finance to ensure pricing assumptions, GTN forecasts, and contracting scenarios are accurately reflected in financial planning and forecasting models
• Monitor payer contracting trends, competitive pricing dynamics, and reimbursement environments to inform pricing strategy and market access planning
• Provide strategic oversight of government pricing considerations, including AMP, Best Price, Medicaid rebate implications, and 340B pricing impacts, ensuring pricing and contracting strategies align with regulatory requirements
• Support the development of pricing governance processes and provide strategic recommendations to senior leadership regarding pricing decisions and contracting strategies
• Partner with Legal and Compliance to ensure pricing and contracting practices adhere to regulatory requirements and company compliance standards
• 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

Senior Manager, Data Management

Manager – Trial Operations

Director, Quality Assurance, GCP

Director, Quality Assurance – GMP

Director, Quality Assurance – GMP

Director, Medical Affairs – Epilepsy

Director, Regulatory Affairs – Commercial, Advertising & Promotion

Senior Manager – Enterprise Integration, Data Engineering

Executive Director – Total Rewards

Senior Systems Engineer – Microsoft

Director, Human Resources

Director, CMC, Drug Substance

Senior Manager, Trial Operations

Senior Manager, Trial Operations

Director, Pricing & Contracting