Senior Medical Director, Clinical Development (Psychiatry)

Job description

***Who We Are:*** Xenon Pharmaceuticals ([NASDAQ:XENE](https://www.nasdaq.com/market-activity/stocks/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](https://xenon-pharma.com/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 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for 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 Director, Clinical Development** to join our team. This incumbent is a key contributor to clinical development of the Company’s portfolio of products and product candidates from Discovery to Phase 3 and post-approval activities, focusing on leadership of clinical studies and programs as required, medical leadership, medical and safety monitoring (as Medical Monitor) for assigned company’s products. The Senior Medical Director, Clinical Development will have medical knowledge of psychiatry and preferably neurology, recent development advances in psychiatric therapeutics landscape, relevant drug development experience, be a collaborative, inspirational, resilient leader, have a broad strategic view of therapeutic area and be well-versed in high quality trial execution. Ability for highly collaborative approach to working with others across a range of Discovery, Clinical Development, and Commercial functions is an expectation. The Senior Medical Director, Clinical Development will interact with all levels of internal staff as well as external stakeholders, including, but not limited to Key Opinion Leaders, Advisory Boards and Committees, and Health Authorities. This position reports to the Vice President, Clinical Development, Psychiatry and will have flexibility to be based out of Boston, MA or remote locations. Boston based candidates will require a minimum of two onsite days per week. **RESPONSIBILITIES:** - Lead and manage clinical development studies in psychiatry, primarily in major depressive disorder (MDD) including design and medical oversight throughout clinical development stages in collaboration with internal colleagues. - Ability to serves as medical monitor (MM) and interact collaboratively, collegially and competently with clinical research sites and investigators globally, to represent the Company, Product and protocol in the most optimal manner. - Contribute to the preparation and on-going revisions and strategy of Clinical Development Plans for assigned products and product candidates, collaborating with other key internal functions including Translational Drug Development, Biostatistics, Clinical Operations, Regulatory, Medical Affairs and Commercial. - Provide strategic and scientific leadership for trial designs, both standard and novel for both large and rare disease indications. - Review scientific literature and develop product and indication knowledge to understand and effectively communicate information relating to products, product candidates and therapeutic areas. - Serve as therapeutic area expert to provide scientific input into the development, execution, and communication of clinical trial(s). - Maintain a high degree of awareness of the external research and regulatory environments and track emerging study data to ensure appropriateness of clinical development plans and trial endpoints. - In collaboration with internal colleagues, identify and build relationships with KOLs and other experts to gain scientific and medical input on a variety of topics related to clinical development. - Draft and/or review clinical and scientific sections of regulatory submissions, including INDs and NDAs, and discussion documents for interactions with regulatory and Health Authorities. - Draft and review documents (including Investigator Brochures, clinical study protocols, and clinical study reports and regulatory submissions), as well as scientific publications (incl posters, abstracts, and manuscripts). - Participate in the review and interpretation of clinical trial data and provide insight into the clinical relevance of trial results. - Provide analyses of development strategies and options for discovery pipeline programs, including input into Proof-of-Concept trials, biomarker approaches, new research opportunities etc. - Support in-licensing and out-licensing activities and partner relationships as needed. - Present proposals and plans to variety of audiences, including to the Company’s Executive Leadership Team. - Contribute to the development of short- and long-term goals for the department in accordance with overall Company and Development strategies. - Participate in the planning and management of budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies. - Serve as clinical expert to provide clinical/scientific knowledge into the development, execution, and communication of a global clinical trial(s). - Actively collaborate with external clinical and other vendors on medical, scientific, psychometric data quality expectations, reviews and actions to ensure high quality and high integrity data generation. - Domestic and international travel may be required in the course of regular business activities. - 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:** - MD or MD/PhD with strong and versatile clinical development experience, ideally in psychiatry, preferably MDD. Experience in neurology disorders is an asset. - Minimum 8 years progressive development experience in the pharmaceutical or industry required (e.g., regulatory agency, academic research etc.) Majority of relevant experience is obtained in the industry setting. - Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes. - Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 3 clinical trials experience, including experience with clinical trials from concept to clinical study report is required. - Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements. - Growth mindset, leadership experience and leadership potential as a clinical development expert and Medical Monitor in a complex matrix environment. - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication. - Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path. 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.