Director/Senior Director, CMC, Drug Substance

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 Director/Senior Director, CMC, Drug Substance to join our team. The Director/Senior Director, CMC Drug Substance will help manage and oversee the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for late-stage clinical trials through validation. The Director/Senior Director will be a key member of a highly collaborative internal CMC team, primarily managing API development programs and manufacturing campaigns (i.e. registration, validation), and managing contract development and manufacturing organization (CDMO) selection and technical transfer processes. This position reports to the Executive Director, CMC, Drug Substance 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. This role is a hybrid position, requiring a minimum of 2 days per week in the office. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

Responsibilities

• Manage and oversee the development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards.
• Evaluate, recommend, and manage qualified CDMOs for the manufacture of API for clinical trials, as well as for commercial use.
• Serving as the subject matter expert, participate in audits and inspections of API CDMOs in conjunction with Quality Assurance.
• Collaborating closely with the internal process chemistry team, manage API process technology transfer to the Company's CDMOs, including process validation and the establishment and refinement of suitable specifications for APIs.
• Work closely with Supply Chain and CMC Drug Product colleagues to translate demand forecasts (both clinical and commercial) into API manufacturing plans.
• Author (in conjunction with Technical Writing) and/or act as a key reviewer of core CMC documents/modules and other forms of submissions and responses to FDA and other Competent
• Authorities providing strategic oversight and consistency for regulatory interactions, including, but not limited to, IND/NDA/MAA/IMPD filings and periodic updates thereto.
• Plan and manage API-related budget proposals and approved project budgets in accordance with the Company's strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports in accordance with the Company's Human Resource policies and practices.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• 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

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