Medical Director Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety

📋 Description

• • Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing life-changing therapeutics for patients with unmet medical needs. We are actively seeking talented individuals who thrive in a collaborative, inclusive, and productive environment to join our growing team.
• • Our mission is to advance an exciting product pipeline targeting indications with high unmet medical need, including epilepsy and depression. The azetukalner program, a clinically validated potassium channel modulator, is in late-stage clinical development. Following positive Phase 2b results in adult focal epilepsy patients, our Phase 3 epilepsy program is evaluating azetukalner for focal onset seizures and primary generalized tonic-clonic seizures. Patient enrollment for the Phase 3 X-TOLE2 study is complete, with topline data expected in March 2026. Concurrently, we are progressing multiple Phase 3 trials for azetukalner in major depressive disorder (MDD) and bipolar depression (BPD), building on promising Phase 2 X-NOVA trial data.
• • Beyond our clinical programs, our discovery labs are at the forefront of neuroscience, leveraging extensive ion channel expertise to identify validated drug targets and develop novel product candidates. We have initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, for pain management. With a strong financial foundation, we are building a fully integrated, premier neuroscience company encompassing discovery, clinical development, corporate, and commercial operations.
• • We are seeking a highly motivated and experienced Medical Director / Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety to play a pivotal role in ensuring the safety of our investigational and marketed products.
• • This role is accountable for defining and executing the medical safety strategy for assigned Xenon products throughout their lifecycle, from early development through post-approval.
• • Key responsibilities include identifying and characterizing product safety risks, developing and implementing effective risk mitigation strategies, and ensuring accurate safety risk language is incorporated into all relevant clinical development and regulatory documentation.
• • The successful candidate will be responsible for conducting comprehensive benefit-risk assessments, overseeing safety surveillance activities during clinical development and post-marketing, and ensuring strict adherence to all applicable US and international legal and regulatory requirements for pharmacovigilance, signal management, and risk management.
• • You will lead a cross-functional Safety Risk Management Team (SRMT), fostering collaboration with key departments including Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics and Programming, Data Management, Regulatory Affairs, Medical Affairs, Non-clinical Safety, Quality Assurance, and Legal.
• • This position reports to the Vice President, Drug Safety and Pharmacovigilance, Medical Safety. While the role is based in our Needham, MA office, we offer flexibility and will consider remote locations for exceptional candidates.
• • The level of the position will be commensurate with the candidate's education and extensive industry experience.
• • Responsibilities include:
• • Leading the global Medical Safety strategy for assigned products, encompassing the development and maintenance of the overall safety profile, safety risk register, risk mitigation plans, safety risk communication, and surveillance strategies across the entire product lifecycle (First-In-Human to post-marketing).
• • Ensuring the timely delivery of safety contributions, adhering to Drug Safety and Pharmacovigilance (DSPV) processes, to support clinical development strategies and plans.
• • Serving as the Product Global Safety Lead (GSL) and chairing the SRMT, leading cross-functional safety surveillance activities.
• • Critically reviewing safety data from all sources, escalating potential safety signals to safety governance as per established SOPs and work instructions.
• • Cultivating strong working relationships and alignment with the three core pillars of pharmacovigilance: Risk Management and Safety Governance, Safety Surveillance and Aggregate Reports, and Pharmacovigilance Operations, Compliance, and Systems.
• • Building robust working relationships with cross-functional colleagues, particularly Clinical Development physicians and Regulatory Affairs leads, and as needed, with Biostatistics and Programming, Data Management, Medical Affairs, Non-Clinical Safety, Quality Assurance, and Legal departments.
• • Championing a culture of shared responsibility for patient safety, proactively managing medical safety risks through effective communication and escalation to senior leadership when necessary.
• • Ensuring rigorous adherence to regulatory safety compliance and the company's development strategy.
• • Providing essential medical safety expertise for safety surveillance, signal detection, risk management, benefit-risk assessment, and periodic safety update reports throughout the product lifecycle.
• • Ensuring non-clinical study safety data is thoroughly reviewed and integrated into the safety risk register and risk mitigation strategies for study protocols, including dose escalation considerations.
• • Supporting New Drug Application (NDA) submissions and preparing ad hoc documents and communications to Regulatory Agencies.
• • Assisting the Head of Medical Safety in ensuring all safety-related activities comply with applicable local and global regulatory standards and pharmacovigilance exchange agreements with corporate partners.
• • Overseeing the timely submission of all safety reports to worldwide health authorities in compliance with global regulatory requirements and industry best practices.
• • Managing the careful and timely review of safety concerns escalated by internal and external stakeholders, including regulatory authorities, and developing appropriate safety assessment strategies.
• • Providing expert guidance and ensuring alignment of safety sections in clinical study documents, including Study Protocols, Informed Consent Forms (ICFs), and Investigator's Brochures (IB) Reference Safety Information (RSI) with the most current product-specific Safety Risk Language.
• • Guiding the development of safety sections for various clinical documents, such as Statistical Analysis Plans (SAP), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), publications, manuscripts, and other relevant documents.
• • Conducting medical reviews of Individual Case Safety Reports (ICSRs) in the Company's Global Safety Database, including case narratives, MedDRA coding, labeling, causality assessment, company comments, and query resolution for assigned products.
• • Providing critical medical safety input for the development of Aggregate Safety Reports (ASR), including Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), Periodic Adverse Drug Experience Reports (PADER), IND Annual Safety Reports, and responses to health authority requests for safety information.
• • Proactively identifying key medical safety issues, trends, and early risks for assigned products, and developing and recommending effective mitigation strategies.
• • Collaborating with Clinical Development and Medical Affairs to develop publications and clinical data communications, including the review of scientific publications such as posters, abstracts, and manuscripts.
• • Acting in accordance with Company policies, including the Code of Business Conduct and Ethics, and ensuring these policies are understood and followed by any direct reports.
• • Some international travel may be required.
• • Performing other duties as assigned.