Xenon Pharmaceuticals
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Xenon Pharmaceuticals is a clinical-stage biopharmaceutical company committed to developing innovative therapies to address neurological disorders with signific
6 Jobs
Director, Pricing and Contracting
Xenon PharmaceuticalsXenon Pharmaceuticals is a clinical-stage biopharmaceutical company committed to developing innovative therapies to address neurological disorders with signific
Title: Director, Pricing & Contracting Location: Boston Department: Commercial Job 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 (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 Director, Pricing and Contracting to join our Market Access team. This role will be responsible for U.S. pricing and contracting strategy to support optimal market access, reimbursement, and financial performance for Xenon’s portfolio. This role will lead the development of contracting strategies with national/regional payer organizations, PBMs, and government payer segments as well as pricing strategy, gross-to-net modeling, and payer contracting strategies that support both product launch planning and lifecycle management. This individual will work closely with the payer field team to support contract negotiations and ensure pricing and contracting decisions align with overall market access strategies and company financial objectives. This role will collaborate cross-functionally with Finance, Legal, Compliance, Medical Affairs, and Commercial leadership to evaluate pricing scenarios, inform access strategy decisions, and support the successful commercialization of Xenon products. This role reports to the Senior Director of Market Access Strategy and Operations and is based out of Boston, MA, USA, in our Needham office. 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. RESPONSIBILITIES: - 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 QUALIFICATIONS: - Bachelor’s degree required; advanced degree or MBA preferred - 10+ years of experience in the pharmaceutical or biotechnology industry, including at least 5 plus years in Pricing, Contracting, or Market Access roles - Demonstrated experience developing U.S. pricing strategy, including launch pricing recommendations and lifecycle pricing management for specialty-lite and/or specialty therapies - Proven experience developing and managing gross-to-net (GTN) models to support financial forecasting, pricing scenario planning, and contracting strategy - Demonstrated experience designing and implementing payer contracting strategies, including rebate structures and negotiations with pharmacy benefit managers (PBMs), national payer organizations, government payers and regional health plans - Experience evaluating government pricing implications including AMP, Best Price, Medicaid rebate exposure, and 340B pricing considerations - Experience supporting product launches or late-stage pipeline assets strongly preferred - Strong financial modeling and analytical skills with the ability to translate complex pricing and contracting scenarios into strategic recommendations - Demonstrated ability to collaborate cross-functionally with Finance, Legal, Compliance, Medical Affairs, and Commercial teams - Experience supporting pricing governance processes and cross-functional pricing decision frameworks preferred - Strong leadership, communication, and executive presentation skills - Ability to thrive in a fast-paced, growth-stage environment 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.
Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety
Xenon PharmaceuticalsXenon Pharmaceuticals is a clinical-stage biopharmaceutical company committed to developing innovative therapies to address neurological disorders with signific
Title: Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety Location Boston Employment Type Full time Location Type Hybrid Department Clinical Development Pharma covigilance Compensation Base Salary $285K – $369K • Offers Equity • Offers Bonus Job 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 (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. 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 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: - Lead the global Medical Safety strategy for assigned company’s product including development and maintenance of the overall safety product profile of the product including 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. 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 colleagues, and in particular close working relationship with Clinical Development physicians and Regulatory Affairs leads, and as needed with Biostatistics and Programming, Data Management, Medical Affairs, Non-Clinical Safety lead, Quality Assurance and Legal departments amongst others. - Foster a culture that promotes a shared company-wide responsibility for “Patient Safety First” by: - Applying an initiative-taking approach to manage medical safety risks through communication with pears and when needed escalation to senior leadership. - Ensuring adherence to regulatory safety compliance and company’s development strategy. - Responsible for contributing 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 that safety data from non-clinical studies are reviewed and considered when creating and updating safety risk register and risk mitigation strategies in study protocols (e.g. dose escalation). - Support NDA submission and or ad hoc documents and communications to Regulatory Agencies for assigned Company’s product throughout the product lifecycle from First-In-Human to post-marketing. - The role supports the Head of Medical Safety in ensuring that all safety related activities comply with applicable local and global regulatory standards and pharmacovigilance exchange agreements with corporate partners - Activities include timely submission of all safety reports to worldwide health authorities and in compliance with applicable with worldwide regulatory safety reporting requirements and industry-standard best practice. - Ensure careful and timely review of safety concerns escalated by internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment for assigned Company’s product. - Provide guidance and ensure that safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), and IB Reference Safety Information (RSI) are aligned with the most current Company’s product specific Safety Risk Language. - Provide guidance for safety sections of clinical study documents including 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. - Responsible for medical review of ICSRs in Company’s Global Safety Database including but not limited to case narrative, MedDRA coding, labeling, causality, company comment and queries for the assigned Company’s product. - Responsible for the medical safety input for the development of Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Reports (PADER), IND Annual Safety Reports, and responses to health authorities’ requests for safety information. - Identify key medical safety issues, trends, and early risk identification for assigned Company’s product and proactively develop and recommend effective mitigation strategies. - Collaborate with Clinical Development and Medical Affairs to develop publications and clinical data communications; review scientific publications such as posters, abstracts, and manuscripts. - 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 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 report, DSUR, PBRER, RMP/REMS, and RSI. - Experience in all phases of global drug development process from pre-IND through NDA and post-licensure, clinical development and NDA submissions. - Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations. - Experience with Argus or ARISg systems, Global Safety Database data mining and MedDRA coding. - Excellent interpersonal communication and presentation skills - Time management skills with ability to prioritize meeting required deadlines. - Ability to multitask and work under tight deadlines while prioritizing attention to important details and high-quality work in a dynamic environment. - Strong ability to work collaboratively in dynamic small teams of internal and external partners that are a part of a fast-paced environment. 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.
Director, Quality Assurance
Xenon PharmaceuticalsXenon Pharmaceuticals is a clinical-stage biopharmaceutical company committed to developing innovative therapies to address neurological disorders with signific
Title: Director, Quality Assurance, GCP Location: Boston Department: Development - R&D Operations Base Salary $216.4K – $234.9K • Offers Equity • Offers Bonus Job 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 (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. About the Role: We are seeking a Director, Quality Assurance, GCP/GLP to join our team. We are building our Quality function to support Xenon’s clinical development programs, as well as expand quality initiatives across the company. This person will provide Quality leadership primarily in support of early-stage clinical programs (pre-phase 3) and non-clinical studies. This position will contribute to inspection readiness initiatives and for ensuring compliance within R&D Program. The successful candidate must have a strong clinical/non-clinical quality background, including providing Quality support for study teams, auditing, and inspections. This position must have exceptional interpersonal skills, excellent communication skills, and a collaborative and pragmatic approach to Quality. This position reports to the Executive Director, Quality Assurance, GCP 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. RESPONSIBILITIES: · Lead and manage quality oversight of the Company’s GLP programs, including the GLP audit program, collaborating with Quality Systems to develop an annual GLP audit plan. · 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 the quality of the Company’s R&D programs to safeguard study participants’ safety and rights and ensure the quality, integrity, and credibility of data generated. · Identify and escalate critical quality issues appropriately to QA Management. · Assist with the preparation and coordination of regulatory inspections held remotely and onsite at the Company’s offices, clinical trial sites, and contract service provider facilities, as needed. · Maintain respectful, inclusive, and effective cross-functional communications, collaborating with internal and external stakeholders on strategy and implementation of quality principles and regulatory requirements while remaining independent. · Ensure compliance with relevant legislation and regulations. · Develop and propose short- and long-term objectives for the GLP/GCP functions in accordance with overall Company and Quality strategies. · 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 · Other duties as assigned QUALIFICATIONS: · Bachelor’s degree in a scientific or health field with at least 10 years of GxP QA experience, 8+ years GCP QA, supporting both development and commercial programs in the pharmaceutical or biotechnology industry. · A minimum of 5 years’ management level experience in a pharma or biotech environment. Job level commensurate with years of experience. · Contemporary knowledge of GLP/GCP/GVP regulations, guidelines, current industry trends, standards, and methodologies. · Experience interacting with regulatory inspectorates (e.g., FDA, Health Canada, EMA, MHRA) is desirable. · Sound understanding of all phases of the drug development process and the interdependencies with other functional areas. · Experience in conducting audits, adapting issues into effective CAPAs, and evaluating trends to mitigate risks. · Ability to prioritize work effectively to manage several complex projects in parallel, and successfully achieve critical milestones and expected deliverables within established timelines and budgets. · Must be able to demonstrate strategic thinking, excellent organizational skills and be able to drive project teams forward while having willingness to do hands on work to achieve goals. · Demonstrated ability to interact professionally and communicate clearly, concisely, and consistently both verbally and in writing with internal and external stakeholders. · Proven ability to work independently and collaboratively as part of a multidisciplinary team. · Proficient people management skills including mentorship, negotiation, and conflict resolution. 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.
Senior Director, CMC, Drug Substance
Xenon PharmaceuticalsXenon Pharmaceuticals is a clinical-stage biopharmaceutical company committed to developing innovative therapies to address neurological disorders with signific
Manage and oversee the development and manufacturing of small molecule APIs, evaluate and select CDMOs, and collaborate on process technology transfer to ensure compliance with quality and regulatory standards.
Director, Chemistry, Manufacturing, and Controls, Drug Product
Xenon PharmaceuticalsXenon Pharmaceuticals is a clinical-stage biopharmaceutical company committed to developing innovative therapies to address neurological disorders with signific
Title: Director, CMC, Drug Product Location: Boston Department: Development - R&D Operations Job 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 (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. About the Role: We are seeking a Director, CMC, Drug Product to join our team. The Director, CMC, Drug Product manages and oversees the late phase process development, validation and commercial manufacturing of cGMP drug products for deployment in late-stage clinical trials and commercial distribution. The Director, CMC, Drug Product will be a key member of a highly collaborative internal CMC team, primarily managing drug product process validation, launch and commercial manufacturing through CDMOs and CROs. This position reports to the Executive Director, CMC, Drug Product and will be based out of our Boston, MA, USA in our Needham office or in our Burnaby, BC, Canada office. We will consider other jurisdictions for exceptional candidates. This role is a hybrid position; hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week. The level of the position will be commensurate with the candidate’s education and industry experience. RESPONSIBILITIES: · Lead teams in late-stage process development and scale up, process validation (PPQ) and commercial manufacturing of small molecule drug products. · Oversee late phase development and manufacturing processes, ensuring compliance with quality and regulatory standards. · Manage development activities related to late-stage process development and scale up, FMEA analysis, process validation (PPQ) and preparation for commercial launch of small molecules drug products at partner CDMOs and CMO. · Manage on going commercial manufacturing and primary packaging of approved small molecule drug products by working with supply chain, quality and regulatory groups. Serve as CMC SME of commercial drug product supply. · Manage the selection of late-stage and commercial CDMOs while considering capabilities, capacities, redundancy and quality. · Provide input for drug product stability programs and help select appropriate packaging for clinical development and commercial use. · Evaluate, recommend, and manage qualified CDMOs for manufacturing drug products for late-stage clinical trials, scale-up, registration, validation and commercial use. Collaborate with Quality Assurance to manage audits and inspections of CDMOs and on manufacturing investigations. · Author and review core CMC documents/modules and other submissions and responses to FDA and other Competent Authorities, ensuring strategic oversight and consistency for regulatory interactions, including IND/NDA/MAA/IMPD filings and periodic updates. · Stay informed on pharmaceutical development and manufacturing industry science, regulatory guidelines and competitive trends to provide informed recommendations. · Develop and propose objectives in alignment with overall company strategies and plans. · Collaborate with development and commercial partnerships, including ex-US collaborations, to ensure global alignment and integration of strategies. · 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 domestic and international travel will be required. · Other duties as assigned. QUALIFICATIONS: · PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or a related discipline with at least 10 years of relevant management experience in a pharma or biotech environment. Candidates with an MSc and relevant experience may also be considered. · Extensive experience in managing late-stage drug product manufacturing and commercialization activities (registration, process scale up, validation and launch), including oversight of external Contract Manufacturing Organizations (CMOs). · Experience in developing formulations of small molecule solid oral and parenteral dosage forms is a plus. · Strong background in drug product manufacturing sciences with experience with multiple solid oral manufacturing approaches such as capsules, tablets, spray drying, granulation, blending, bottling and blistering. · Demonstrated success in transitioning development assets to commercial products and ongoing support of commercial manufacturing. · Experience contributing to and developing CMC sections in US and ex-US regulatory filings. · In-depth knowledge of cGMP regulations, guidance, principles, and best practices related to drug product development and manufacture. · Proficiency in Failure Modes Effect Analysis (FMEA) and establishment of Critical Process Parameters (CPPs). · Experience with CDMO selection, management, contracting, and issue resolution. · Excellent oral and written communication, leadership, and interpersonal skills, with the ability to build credibility and trust both inside and outside the company. · Proven ability to build and develop high-performing teams, with strong delegation and conflict resolution skills. 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.
Senior Medical Science Liaison (NYC Tri-State)
Xenon PharmaceuticalsXenon Pharmaceuticals is a clinical-stage biopharmaceutical company committed to developing innovative therapies to address neurological disorders with signific
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 and depression. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b X-TOLE study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In November 2025, we announced the completion of patient enrollment in our Phase 3 X-TOLE2 study, and topline data are anticipated in March 2026. We also have multiple Phase 3 azetukalner clinical trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. We have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, in 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 Senior Medical Science Liaison (Senior MSL). This is an opportunity to join Xenon in a field-facing role to shape and advance the MSL function in support of Medical Affairs and Clinical Development teams. This role will engage external Healthcare Providers (HCPs), Key Opinion Leaders (KOLs), and patient groups to provide education on Xenon’s pipeline in epilepsy. This position reports to the Regional Senior Director, Field Based Medicine, and the Senior MSL will be responsible for the NYC Tri-State Region: New York City, Long Island, New Jersey, & Connecticut. Preference is for the selected individual to reside in New York City. The successful candidate is a clinical or scientific professional with a passion for science and deep scientific knowledge and a proven ability to communicate complex scientific and medical information clearly. This candidate seeks to understand the needs of healthcare providers, patients, and families, and collaborates to solve critical scientific and business challenges. RESPONSIBILITIES: - Identify, develop and maintain valued and productive scientific relationships with key external stakeholders including KOLs, HCPs, payors, academic and healthcare institutions, and advocacy groups. - Act as a key scientific resource to communicate up-to-date medical, clinical, and scientific information about Xenon’s neurology and epilepsy products and pipeline. - Advance Xenon’s scientific platform and medical information in alignment with corporate and medical objectives. - Engage in projects and/or initiatives aligned to medical strategies and objectives; adapt plans and tactics for the assigned territory. - Identify and report timely and relevant scientific/clinical insights, trends, opportunities, and threats for targeted products. - Collaborate with internal clinical development teams to enhance patient enrollment in Xenon-sponsored clinical trials. This includes investigator identification for clinical programs in epilepsy. - Respond to and document unsolicited requests for scientific information. - Lead assigned national and/or regional congress activities in accordance with Medical Affairs strategies and plans. - Provide instruction, coaching and mentoring to new or less experienced MSLs. - Travel domestically up to 50% of the time, including overnight travel as business needs require. International travel may be required on an ad-hoc basis. - 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. QUALIFICATIONS: - Minimum of a relevant doctorate degree (i.e. M.D., PhD, PharmD, DPH, DNP). - Minimum 5 years relevant MSL related experience required, with 8+ years strongly preferred. Experience in neurology therapeutic area or epilepsy required - Established relationships with KOLs and knowledge of institutions in neurology; epilepsy strongly preferred. - Clinical trial development and drug launch experience are strongly preferred. - Able to communicate accurately, concisely, credibly, and confidently; easily understands other points of view and responds appropriately; adjusts communication according to the audience. - Delivers reliably against goals; proven ability to work both independently and cross-functionally; demonstrates a willingness and aptitude to learn if not yet well-versed. - Knowledge of clinical research processes, FDA regulations, and OIG guidelines required. 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.