Senior Medical Director, Clinical Development (Psychiatry)

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients with high unmet medical needs. We are advancing an exciting product pipeline addressing epilepsy, depression, and pain, including our Phase 3 azetukalner program—the most advanced, clinically validated potassium channel modulator in late-stage development for multiple indications. Recent milestones include positive topline data from the Phase 3 X-TOLE2 study in focal onset seizures (FOS) and anticipated FDA submission in Q3 2026. Additional Phase 3 trials are underway in major depressive disorder (MDD) and bipolar depression (BPD), alongside early-stage programs targeting pain (e.g., XEN1701 for Nav1.7 and XEN1120 for Kv7). Backed by a strong balance sheet, Xenon is building a fully integrated neuroscience company with robust discovery, clinical, and commercial operations.

About the Role

We are seeking a Senior Medical Director, Clinical Development to lead and manage clinical development studies and programs from Discovery through Phase 3 and post-approval activities. This role focuses on medical leadership, safety monitoring (as Medical Monitor), and strategic oversight of psychiatry-focused programs, primarily in major depressive disorder (MDD). The ideal candidate will have deep expertise in psychiatry (neurology experience is an asset), a collaborative leadership style, and a broad strategic view of therapeutic areas. This position requires close collaboration across Discovery, Clinical Development, and Commercial functions, as well as engagement with external stakeholders, including Key Opinion Leaders (KOLs), Advisory Boards, and Health Authorities. The role reports to the Vice President, Clinical Development, Psychiatry, and offers flexibility to be based in Boston, MA (minimum two onsite days per week) or remotely.

Responsibilities

• Lead and manage clinical development studies in psychiatry, including design and medical oversight throughout all stages, in collaboration with internal teams.
• Serve as Medical Monitor (MM), interacting collaboratively with global clinical research sites and investigators to represent the company, product, and protocol.
• Contribute to the preparation and ongoing revision of Clinical Development Plans for assigned products, collaborating with Translational Drug Development, Biostatistics, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams.
• Provide strategic and scientific leadership for trial designs, including standard and novel approaches for both large and rare disease indications.
• Review scientific literature to develop product and indication knowledge, ensuring effective communication of relevant information.
• Serve as a therapeutic area expert, providing scientific input into the development, execution, and communication of clinical trials.
• Maintain awareness of external research and regulatory environments, tracking emerging data to ensure clinical development plans and trial endpoints remain appropriate.
• Identify and build relationships with KOLs and experts to gain scientific and medical input on clinical development topics.
• Draft and/or review clinical and scientific sections of regulatory submissions (e.g., INDs, NDAs) and discussion documents for interactions with regulatory authorities.
• Draft and review key documents, including Investigator Brochures, clinical study protocols, clinical study reports, regulatory submissions, and scientific publications (e.g., posters, abstracts, manuscripts).
• Participate in the review and interpretation of clinical trial data, providing insight into the clinical relevance of results.
• Analyze development strategies and options for discovery pipeline programs, including input into Proof-of-Concept trials, biomarker approaches, and new research opportunities.
• Support in-licensing and out-licensing activities and partner relationships as needed.
• Present proposals and plans to diverse audiences, including the Executive Leadership Team.
• Contribute to the development of short- and long-term departmental goals aligned with company and development strategies.
• Participate in budget planning and management in accordance with company strategic plans and Finance policies.
• Act as a clinical expert, providing scientific knowledge to ensure high-quality execution and communication of global clinical trials.
• Collaborate with external vendors on medical, scientific, and psychometric data quality expectations, reviews, and actions to ensure high-integrity data generation.
• Domestic and international travel may be required for regular business activities.
• Recruit, lead, develop, and evaluate direct reports (if any) in accordance with company HR policies and practices.
• Act in accordance with company policies, including the Code of Business Conduct and Ethics, and ensure compliance among direct reports.
• Perform other duties as assigned.

Qualifications

• MD or MD/PhD with strong and versatile clinical development experience, ideally in psychiatry (preferably MDD); neurology experience is an asset.
• Minimum 8 years of progressive development experience in the pharmaceutical or biotech industry (e.g., regulatory agency, academic research); majority of experience should be industry-based.
• Knowledge of pharmaceutical product development, lifecycle management, and commercialization processes.
• Experience developing study concepts and clinical trial designs with cross-functional input, including biostatistics, observational research, and patient-reported outcomes in Phase 3 trials. Experience from concept to clinical study report is required.
• Familiarity with Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations, and applicable international regulatory requirements.
• Growth mindset with leadership experience and 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, problem-solving abilities, and superior judgment with a balanced, realistic understanding of issues and resolution paths.

Benefits

• Competitive total rewards program including base salary, target bonus, and stock options.
• Comprehensive benefits: medical, dental, vision, short- and long-term disability, accidental death & dismemberment, and life insurance.
• Employee Assistance Program (EAP) and travel insurance.
• Retirement savings programs with company matching contributions.
• Paid time off: vacation, personal days, sick days, and an end-of-year company shutdown.
• Employee development opportunities, including a Tuition Assistance program for advanced degrees and an expanding Training, Learning & Development program.

Pay

Compensation Range: $344,000 – $380,400.