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

About the role

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 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets. 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. We are seeking a Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety to join our team. The Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety will be accountable for setting the medical safety strategy for the assigned Company's product in early or late state development and/or post approval. They will be responsible for defining the product's safety risks, safety risk mitigation strategies and safety risks language for inclusion in clinical development and regulatory documents. They will be also accountable for the benefit-risk assessment of the assigned Company's product throughout the product lifecycle (from First-In-Human to post-marketing), safety surveillance during clinical development and post-approval, and ensuring corporate compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management of the assigned Company's product. The successful candidate will lead a cross-functional Safety Risk Management Team (SRMT), and collaborate closely with colleagues in Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics and Programming, Data Management, Regulatory Affairs, Medical Affairs, non-clinical safety lead, QA and Legal departments amongst others. This position reports to the Vice President, Drug Safety and Pharmacovigilance, Medical Safety, and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate's education and industry experience. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

Responsibilities

• Ensure timely delivery of safety contributions, in accordance with DSPV processes, to support clinical development strategies and plans throughout the product lifecycle from First-In-Human to post-marketing.
• Lead cross functional safety surveillance activities as a product GSL and chair of the SRMT. Key contributor to the review of safety data from all sources and escalate potential safety signals to safety governance when warranted as per governance SOP and work instructions (WI).
• Develop a strong working relationship and alignment with the three other pillars of pharmacovigilance: Risk Management and Safety Governance, Safety Surveillance and Aggregate Reports, and Pharmacovigilance Operations, Compliance and Systems.
• Develop a strong working relationship with cross-functional

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