Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Med
Xenon Pharmaceuticals, Needham Heights, Massachusetts, us, 02494
Overview
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. Xenon is advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our Phase 3 azetukalner program represents a leading, clinically validated potassium channel modulator in late-stage development for multiple indications. Building upon the positive results from our Phase 2b X-TOLE study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple trials evaluating azetukalner in focal onset seizures and primary generalized tonic-clonic seizures. In November 2025, patient enrollment in our Phase 3 X-TOLE2 study was completed, and topline data are anticipated in March 2026. We also have multiple Phase 3 azetukalner trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 X-NOVA trial. We have initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, in pain. We are backed by a strong balance sheet to support growth and 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
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 product in early or late state development and/or post-approval. They will define the product’s safety risks, safety risk mitigation strategies, and safety risk language for inclusion in clinical development and regulatory documents. They will also be accountable for the benefit-risk assessment of the product throughout the lifecycle (from First-In-Human to post-marketing), safety surveillance during development and post-approval, and ensuring corporate compliance with applicable US and foreign regulatory requirements for pharmacovigilance, signal management, and risk management. The successful candidate will lead a cross-functional Safety Risk Management Team (SRMT) and collaborate with colleagues across Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics and Programming, Data Management, Regulatory Affairs, Medical Affairs, non-clinical safety, QA and Legal, amongst others. This position reports to the Vice President, Drug Safety and Pharmacovigilance, Medical Safety, and will be based in Boston, MA, USA in our Needham office. Remote work will be considered for exceptional candidates. The level of the position will be commensurate with education and industry experience. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five onsite days per week. Responsibilities
Lead the global Medical Safety strategy for the assigned product, including development and maintenance of the overall safety profile, safety risk register, risk mitigation, safety risk communication, and safety review and surveillance strategies throughout the product lifecycle from First-In-Human to post-marketing.
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. Contribute to reviewing safety data from all sources and escalate potential safety signals to safety governance when warranted as per governance SOP and WI.
Develop strong working relationships with the three pillars of pharmacovigilance: Risk Management and Safety Governance, Safety Surveillance and Aggregate Reports, and Pharmacovigilance Operations, Compliance and Systems.
Develop strong working relationships with cross-functional colleagues, including 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.
Foster a culture that promotes a shared company-wide responsibility for “Patient Safety First” by applying initiative-taking approaches to manage medical safety risks and escalate to senior leadership when needed.
Ensure adherence to regulatory safety compliance and the company’s development strategy.
Contribute medical safety expertise to safety surveillance, signal detection, risk management, benefit-risk assessment, and periodic safety update reports throughout the product lifecycle from First-In-Human to post-marketing.
Ensure safety data from non-clinical studies are reviewed and considered when creating and updating safety risk registers and risk mitigation strategies in study protocols (e.g., dose escalation).
Support NDA submissions and ad hoc documents and communications to Regulatory Agencies for the product throughout the lifecycle.
Support all safety activities to comply with local and global regulatory standards and pharmacovigilance agreements with corporate partners, including timely submission of safety reports to health authorities.
Review safety concerns escalated by internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment.
Provide guidance so that safety sections of clinical study documents (e.g., Study Protocols, ICFs, RSI) align with current Safety Risk Language.
Provide safety guidance for documents including SAP, MMP, CSR, SCS, ICS, Publications, and other materials.
Review ICSRs in the Global Safety Database and handle MedDRA coding, labeling, causality, and queries for the product.
Provide medical input for ASR development (DSUR, PBRER, PADER, IND Annual Safety Reports) and respond to health authority requests.
Identify key safety issues, trends, and mitigation strategies for the product.
Collaborate with Clinical Development and Medical Affairs on publications and data communications, including posters, abstracts, and manuscripts.
Comply with Company policies and ensure direct reports understand and follow them.
Some international travel may be required.
Other duties as assigned.
Qualifications
Medical degree (MD) required, with at least 5 years’ experience in clinical/medical practice preferred.
Minimum of 7 years’ experience as a safety physician in drug safety & pharmacovigilance for products in clinical trial and post-marketing environments. Neuropsychiatry experience is desirable.
Experience authoring and overseeing safety signal assessment reports, DSURs, PBRERs, RMP/REMS, and RSI.
Experience in all phases of global drug development from pre-IND through NDA and post-licensure.
Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other safety regulations.
Experience with Argus or ARISg, Global Safety Database data mining, and MedDRA coding.
Excellent interpersonal communication and presentation skills.
Time management skills with ability to prioritize deadlines.
Ability to multitask and work under tight deadlines with attention to detail and quality.
Strong collaborative ability in fast-paced, cross-functional teams.
Our Total Rewards program includes base salary, target bonus, stock options, and a full range of benefits including medical, dental, vision, disability, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings with company matching contributions. Xenon encourages time to rest and recharge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon values employee development and offers Training, Learning & Development programs, including Tuition Assistance for advanced degrees.
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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. Xenon is advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our Phase 3 azetukalner program represents a leading, clinically validated potassium channel modulator in late-stage development for multiple indications. Building upon the positive results from our Phase 2b X-TOLE study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple trials evaluating azetukalner in focal onset seizures and primary generalized tonic-clonic seizures. In November 2025, patient enrollment in our Phase 3 X-TOLE2 study was completed, and topline data are anticipated in March 2026. We also have multiple Phase 3 azetukalner trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 X-NOVA trial. We have initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, in pain. We are backed by a strong balance sheet to support growth and 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
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 product in early or late state development and/or post-approval. They will define the product’s safety risks, safety risk mitigation strategies, and safety risk language for inclusion in clinical development and regulatory documents. They will also be accountable for the benefit-risk assessment of the product throughout the lifecycle (from First-In-Human to post-marketing), safety surveillance during development and post-approval, and ensuring corporate compliance with applicable US and foreign regulatory requirements for pharmacovigilance, signal management, and risk management. The successful candidate will lead a cross-functional Safety Risk Management Team (SRMT) and collaborate with colleagues across Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics and Programming, Data Management, Regulatory Affairs, Medical Affairs, non-clinical safety, QA and Legal, amongst others. This position reports to the Vice President, Drug Safety and Pharmacovigilance, Medical Safety, and will be based in Boston, MA, USA in our Needham office. Remote work will be considered for exceptional candidates. The level of the position will be commensurate with education and industry experience. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five onsite days per week. Responsibilities
Lead the global Medical Safety strategy for the assigned product, including development and maintenance of the overall safety profile, safety risk register, risk mitigation, safety risk communication, and safety review and surveillance strategies throughout the product lifecycle from First-In-Human to post-marketing.
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. Contribute to reviewing safety data from all sources and escalate potential safety signals to safety governance when warranted as per governance SOP and WI.
Develop strong working relationships with the three pillars of pharmacovigilance: Risk Management and Safety Governance, Safety Surveillance and Aggregate Reports, and Pharmacovigilance Operations, Compliance and Systems.
Develop strong working relationships with cross-functional colleagues, including 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.
Foster a culture that promotes a shared company-wide responsibility for “Patient Safety First” by applying initiative-taking approaches to manage medical safety risks and escalate to senior leadership when needed.
Ensure adherence to regulatory safety compliance and the company’s development strategy.
Contribute medical safety expertise to safety surveillance, signal detection, risk management, benefit-risk assessment, and periodic safety update reports throughout the product lifecycle from First-In-Human to post-marketing.
Ensure safety data from non-clinical studies are reviewed and considered when creating and updating safety risk registers and risk mitigation strategies in study protocols (e.g., dose escalation).
Support NDA submissions and ad hoc documents and communications to Regulatory Agencies for the product throughout the lifecycle.
Support all safety activities to comply with local and global regulatory standards and pharmacovigilance agreements with corporate partners, including timely submission of safety reports to health authorities.
Review safety concerns escalated by internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment.
Provide guidance so that safety sections of clinical study documents (e.g., Study Protocols, ICFs, RSI) align with current Safety Risk Language.
Provide safety guidance for documents including SAP, MMP, CSR, SCS, ICS, Publications, and other materials.
Review ICSRs in the Global Safety Database and handle MedDRA coding, labeling, causality, and queries for the product.
Provide medical input for ASR development (DSUR, PBRER, PADER, IND Annual Safety Reports) and respond to health authority requests.
Identify key safety issues, trends, and mitigation strategies for the product.
Collaborate with Clinical Development and Medical Affairs on publications and data communications, including posters, abstracts, and manuscripts.
Comply with Company policies and ensure direct reports understand and follow them.
Some international travel may be required.
Other duties as assigned.
Qualifications
Medical degree (MD) required, with at least 5 years’ experience in clinical/medical practice preferred.
Minimum of 7 years’ experience as a safety physician in drug safety & pharmacovigilance for products in clinical trial and post-marketing environments. Neuropsychiatry experience is desirable.
Experience authoring and overseeing safety signal assessment reports, DSURs, PBRERs, RMP/REMS, and RSI.
Experience in all phases of global drug development from pre-IND through NDA and post-licensure.
Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other safety regulations.
Experience with Argus or ARISg, Global Safety Database data mining, and MedDRA coding.
Excellent interpersonal communication and presentation skills.
Time management skills with ability to prioritize deadlines.
Ability to multitask and work under tight deadlines with attention to detail and quality.
Strong collaborative ability in fast-paced, cross-functional teams.
Our Total Rewards program includes base salary, target bonus, stock options, and a full range of benefits including medical, dental, vision, disability, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings with company matching contributions. Xenon encourages time to rest and recharge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon values employee development and offers Training, Learning & Development programs, including Tuition Assistance for advanced degrees.
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