Senior Medical Director, Clinical Development (Psychiatry BPD)

Role Summary

Senior Medical Director, Clinical Development to join Xenon’s psychiatry-focused portfolio leadership. This role leads clinical development activities from discovery to Phase 3 and post-approval, providing medical leadership and safety monitoring for assigned products, with emphasis on psychiatry and neurology knowledge, collaborative leadership, and high-quality trial execution. Located in Boston, MA, with potential for other locations for exceptional candidates.

Responsibilities

• Lead and manage clinical development studies in psychiatry, including design and medical oversight across development stages.
• Serve as medical monitor and collaborate with clinical research sites globally to represent the Company, product, and protocol.
• Contribute to Clinical Development Plans for assigned products, coordinating with Translational Drug Development, Biostatistics, Clinical Operations, Regulatory, Medical Affairs, and Commercial.
• Provide strategic and scientific leadership for trial designs across large and rare indications.
• Review literature and develop product/indication knowledge to communicate clinical information effectively.
• Act as therapeutic area expert to provide scientific input into development and communication of trials.
• Monitor external research and regulatory environments to ensure appropriate trial endpoints and development plans.
• Identify and build relationships with KOLs and experts for input on clinical development.
• Draft/review regulatory submissions (INDs, NDAs) and discussions with regulatory authorities; prepare Investigator Brochures, protocols, CRFs, and reports; compose scientific publications.
• Interpret clinical trial data and assess clinical relevance of results.
• Analyze development strategies for discovery programs, including PoC, biomarkers, and new opportunities.
• Support in-licensing/out-licensing and partner relationships as needed.
• Present proposals to executives and contribute to department goals and budgets.
• Collaborate with external vendors to ensure high-quality data generation.
• Domestic and international travel may be required.
• Recruit, lead, and develop direct reports if applicable; uphold company policies and ethics.
• Other duties as assigned.

Qualifications

• MD or MD/PhD with strong clinical development experience, ideally in psychiatry (preferably BPD); neurology background is a plus.
• 8–12 years of progressive development experience in the pharmaceutical/biotech industry.
• 12+ years of relevant management experience; MD with 6+ years of management experience is typical.
• Knowledge of pharmaceutical product development, lifecycle, and commercialization processes.
• Experience designing studies for Phase 1–3 with cross-functional input; end-to-end trial experience required.
• Knowledge of GCP, FDA/EMEA regulations, and international regulatory requirements.
• Growth mindset, leadership potential as a Medical Monitor in a matrix environment.
• Strong written and oral communication skills; ability to present complex concepts clearly.
• Excellent interpersonal and problem-solving abilities with sound judgment.

Skills

• Clinical development leadership
• Medical monitoring and safety oversight
• Regulatory submission preparation
• Trial design and interpretation of data
• Stakeholder engagement (KOLs, advisory boards, health authorities)
• Cross-functional collaboration across discovery, development, and commercial teams

Education

• MD or MD/PhD (psychiatry preferred; neurology asset).

Additional Requirements

• Domestic and international travel as part of role.