Lead and manage clinical development studies in psychiatry, primarily major depressive disorder (MDD), including design and medical oversight throughout clinical development stages.
Serve as Medical Monitor and represent the company, product, and protocol with clinical research sites and investigators globally.
Contribute to preparation and ongoing revisions of Clinical Development Plans for assigned products and candidates in collaboration with internal functions (Translational Drug Development, Biostatistics, Clinical Operations, Regulatory, Medical Affairs, Commercial).
Provide strategic and scientific leadership for trial designs for both standard and novel approaches across large and rare disease indications.
Review scientific literature and develop product and indication knowledge to communicate information effectively.
Serve as therapeutic area expert to provide scientific input into development, execution, and communication of clinical trials.
Maintain awareness of external research and regulatory environments and track emerging study data to ensure appropriateness of development plans and trial endpoints.
Identify and build relationships with KOLs and other experts to gain scientific and medical input.
Draft and/or review clinical and scientific sections of regulatory submissions (INDs, NDAs) and discussion documents for interactions with regulatory and Health Authorities.
Draft and review documents including Investigator Brochures, clinical study protocols, clinical study reports, and regulatory submissions; support scientific publications (posters, abstracts, manuscripts).
Participate in review and interpretation of clinical trial data and provide insight into clinical relevance of results.
Provide analyses of development strategies and options for discovery pipeline programs (e.g., proof-of-concept trials, biomarker approaches, new research opportunities).
Support in-licensing and out-licensing activities and partner relationships as needed.
Present proposals and plans to a variety of audiences including Executive Leadership Team.
Contribute to development of short- and long-term departmental goals aligned with company and development strategies.
Participate in planning and management of budget proposals and approved budgets in accordance with company plans and Finance policies.
Serve as clinical expert for global clinical trials across development, execution, and communication.
Collaborate with external clinical and other vendors on medical/scientific/psychometric data quality expectations, reviews, and actions to ensure high-quality, high-integrity data generation.
Recruit, lead, direct, develop, coach, and evaluate direct reports, if any.
Act in accordance with company policies including Code of Business Conduct and Ethics.
Other duties as assigned.
Domestic and international travel may be required
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 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.
MD or MD/PhD with strong and versatile clinical development experience, ideally in psychiatry (preferably MDD); neurology experience is an asset.
Minimum 8 years progressive development experience in the pharmaceutical/industry setting (majority in industry).
Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
Experience developing study concepts and clinical trial designs with cross-functional input; Phase 3 experience including concept-to-clinical study report.
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and applicable international regulatory requirements.
Leadership experience and potential as a clinical development expert and Medical Monitor in a complex matrix environment.
Ability to present ideas and document complex medical/clinical concepts in written and oral communication.
Strong interpersonal skills and problem-solving with sound judgment