Director, Medical Information

Xenon Pharmaceuticals

  • Needham, Massachusetts
  • 3 days ago
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    Skills

    • Balance Sheetunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Budget Forecastingunmatched
    • Business Ethicsunmatched
    • Business Performance Managementunmatched
    • Call Center Evaluationunmatched
    • Call Center Managementunmatched
    • Call Center Operationsunmatched
    • Call Centersunmatched
    • Clinical Dataunmatched
    • Clinical Study Publicationsunmatched
    • Clinical Trialunmatched
    • Communication Skillsunmatched
    • Contact Managementunmatched
    • Content Developmentunmatched
    • Content Managementunmatched
    • Continuous Improvementunmatched
    • Corporate Policiesunmatched
    • Cross-Functionalunmatched
    • Data Analysisunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • Drug Developmentunmatched
    • Drug Discoveryunmatched
    • Ecosystemsunmatched
    • Geneticsunmatched
    • Health Information Managementunmatched
    • Health Information Technologyunmatched
    • Healthcareunmatched
    • Leadershipunmatched
    • Legalunmatched
    • Maintain Complianceunmatched
    • Medical Affairsunmatched
    • Medical Office Administrationunmatched
    • Medical Recordsunmatched
    • Multitaskingunmatched
    • Neuroscienceunmatched
    • Onboardingunmatched
    • Operational Strategyunmatched
    • Outsourcingunmatched
    • Performance Analysisunmatched
    • Performance Managementunmatched
    • Performance Metricsunmatched
    • Pharmacovigilanceunmatched
    • Phase III Clinical Trialsunmatched
    • Project/Program Managementunmatched
    • Quality Assuranceunmatched
    • Quality Metricsunmatched
    • Reconciliationunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Regulatory Submissionsunmatched
    • Reporting Dashboardsunmatched
    • Resource Utilizationunmatched
    • Riskunmatched
    • Scalable System Developmentunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Strategic Planningunmatched
    • Team Buildingunmatched
    • Team Playerunmatched
    • Time Managementunmatched
    • Training/Teachingunmatched
    • Vendor/Supplier Quality Managementunmatched
    • Vendor/Supplier Selectionunmatched
    • Willing to Travelunmatched
    • Xen Hypervisorunmatched

    Description

    Who We Are:

    Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

    What We Do:

    We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for pain. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.

    About the Role

    We are seeking a Director, Medical Information to support the establishment, scaling, and evolution of the Medical Information (MI) function at Xenon. This role drives functional priorities for, and execution of medical inquiry management, scientific response content development, contact center operations, and digital medical information capabilities to support Medical Affairs, Clinical Development, and Commercial launch readiness. To be successful in this role, you must be a strong operational leader with a service-oriented and collaborative mindset. You are someone driven by scientific rigor, operational excellence, and cross-functional alignment to manage a scalable, future-ready MI ecosystem that integrates data, content, and digital innovation to support healthcare professionals, patients, and internal stakeholders.

    This position reports to the Executive Director, Medical Information and partners closely with Pharmacovigilance & Drug Safety, Quality, Regulatory, Commercial, Market Access, Clinical Development, Legal/Compliance, and Medical Affairs. The position plays a critical role in launch readiness and operational execution, ensuring Xenon delivers high-quality, compliant, and timely medical information for our products and pipeline.

    This position will be based out of Boston, MA, USA in our Needham office. This role is a hybrid position, requiring a minimum of 2 days per week in the office. We will consider other jurisdictions for exceptional candidates.

    RESPONSIBILITIES:

    Strategic Leadership & MI Architecture

    • Operationalize the end-to-end vision, strategy, and execution of the Medical Information function, including contact center operations, digital capabilities, and scientific content management, including readiness for commercialization and oversight of internal/external resources.

    • Build and deploy scalable operating models for MI, including SOPs, workflows, and governance in partnership with Legal, Compliance, PV/DS, Quality, Clin Dev, and Med Affairs.

    • Work with manager and Medical Affairs stakeholders to refine and execute process for the authoring and lifecycle management of Standard Response Letters (SRLs) and scientific content, ensuring accuracy, consistency, and alignment with clinical data, publications, and regulatory requirements.

    • Support MI alignment with enterprise efforts in omnichannel MI delivery and self-service portals.

    Medical Information Operations & Contact Center Leadership

    • Execute and manage MI contact center capability build including vendor selection, onboarding, training, and performance management.

    • Operational oversight and performance management of MI vendors (e.g., contact center, content support), including training, QA, and continuous improvement.

    • Work with internal company stakeholders to develop and manage a Medical Information portal to enable compliant, self-service access to approved content

    • Monitor and report on tactical plan execution to ensure accurate forecasting of budget / spend, resource utilization, and anticipated executional risks.

    Scientific Content & Response Excellence

    • Partner with Medical Affairs, Clinical Development, and Scientific Communications to ensure alignment of scientific messaging within the MI function.

    • Leverage internal and external resources to support content authoring, review and approval and ensure high-quality, consistent scientific responses

    • Ensure content accuracy, consistency, and appropriate risk framing aligned with clinical data, publications, and regulatory milestones and maintain a high-quality content library.

    • Responsible for advancing MI materials through the MLR review processes, ensuring timely approvals and compliance

    • Deliver timely, accurate, high-quality, empathetic, and patient-centered communications

    Inquiry Management & Compliance Oversight

    • Day-to-day management of contact center vendor to ensure efficient inquiry intake, triage/escalation, fulfillment, and documentation processes aligned with regulatory standards, maintaining audit and inspection readiness of MI processes and systems

    • Partner with PV/DS and Quality to ensure appropriate AE/PC identification, reporting and reconciliation

    • Drive adherence to internal policies to ensure compliant handling of medical inquiries, including complex, escalated requests

    Systems, Data & Analytics Leadership, and Cross-Functional Collaboration

    • Partner with IT, Medical Ops and Commercial Ops to maintain scalable MI infrastructure

    • Partner with IT, Medical Ops, and Commercial Ops to ensure MI data flows into appropriate enterprise systems and supports reporting needs

    • Act as the primary operational liaison for MI contact center vendor, Med Affairs functional teams and IT project teams

    • Execute and monitor MI KPIs and dashboards, supporting the translation of data into actionable insights

    People Leadership & Team Development

    • Lead and manage a high-performing, outsourced Medical Information contact center team.

    • Provide training/feedback and oversight of contact center vendor managers and agents while fostering a culture of accountability, collaboration, and continuous improvement.

    Other Responsibilities

    • 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

    • Perform additional duties as assigned to support Medical Affairs objectives and evolving business needs.

    QUALIFICATIONS:

    • PhD, PharmD, MD, or equivalent advanced scientific degree

    • 7+ years of management experience in Medical Affairs with significant (5+ years) Medical Information experience.

    • Demonstrated experience executing and optimizing Medical Information functions in pre-commercial or commercial environments

    • Expertise in scientific response content authoring, inquiry management, and MLR review processes

    • Experience engaging with/managing MI contact centers and external vendors

    • Strong knowledge of regulatory and compliance requirements for MI reporting (FDA, EMA)

    • History of leadership, strategic thinking, and operational execution skills in previous roles

    • Excellent communication and cross-functional collaboration skills

    • Experience working cross‑functionally within Med Affairs, PV/DS, Clin Dev, or related functions

    • Neuroscience experience preferred; epilepsy experience a plus

    • Strong scientific acumen, critical thinking skills, and attention to detail

    • Ability to manage multiple projects and collaborate effectively in a fast-paced, matrix environment

    • Willingness to travel up to 15-20% domestically and internationally as needed

    Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

    Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

    Numbers & Facts

    LocationNeedham, Massachusetts
    Websitehttps://xenon-pharma.com/

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