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Senior Medical Director, Clinical Development

Xenon

Job Overview

Location

Remote

Job Type

Full-time

Full Job Description

📋 Description

• Xenon Pharmaceuticals is a dynamic, neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing groundbreaking therapeutics for patients with significant unmet medical needs. We are driven by a mission to improve lives through innovative science and a dedication to patient well-being. Our culture is built on respect, collaboration, inclusivity, and productivity, and we are seeking exceptional individuals to join our growing team.
• We are advancing a robust pipeline of novel treatments targeting challenging neurological and psychiatric conditions, including epilepsy and depression. Our lead program, azetukalner, a potassium channel modulator, is in late-stage clinical development and has demonstrated significant clinical validation. Building on the success of our Phase 2b X-TOLE study in adult patients with focal epilepsy, our Phase 3 program is actively evaluating azetukalner across multiple indications, including focal onset seizures and primary generalized tonic-clonic seizures. The recent completion of patient enrollment in our Phase 3 X-TOLE2 study, with topline data anticipated in March 2026, marks a significant milestone.
• Beyond epilepsy, we are making substantial progress in major depressive disorder (MDD) and bipolar depression (BPD) with azetukalner, following promising topline data from our Phase 2 X-NOVA clinical trial. Our commitment to innovation extends to our discovery labs, where we leverage our deep expertise in ion channel science to identify validated drug targets and develop new product candidates. Early-stage research programs, including Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, for pain, underscore our dedication to pioneering new therapeutic avenues.
• As a Senior Medical Director, Clinical Development, you will play a pivotal role in shaping the clinical trajectory of our innovative product portfolio, from early discovery through Phase 3 and post-approval activities. This role is critical for the leadership of clinical studies and programs, providing essential medical oversight and strategic direction. You will serve as a key medical and safety monitor (Medical Monitor) for assigned company products, ensuring the highest standards of clinical trial execution and patient safety.
• The ideal candidate possesses deep medical knowledge in psychiatry, with a strong preference for experience in bipolar disorder (BPD), and ideally, a background in neurology. You should be abreast of recent advancements in psychiatric therapeutics and possess substantial drug development experience. We are looking for a collaborative, inspirational, and resilient leader with a broad strategic vision for the therapeutic area and a proven ability to ensure high-quality trial execution. A highly collaborative approach, working seamlessly across Discovery, Clinical Development, and Commercial functions, is paramount.
• You will engage with all levels of internal stakeholders, as well as external experts, including Key Opinion Leaders (KOLs), Advisory Boards, and Health Authorities, to foster strong relationships and gather critical insights.
• Key responsibilities include leading and managing clinical development studies in psychiatry, encompassing study design and medical oversight throughout all development stages, in close collaboration with internal teams. You will serve as a Medical Monitor, interacting professionally and competently with global clinical research sites and investigators, effectively representing Xenon, our products, and study protocols.
• You will contribute significantly to the preparation and ongoing refinement of Clinical Development Plans for assigned products, working cross-functionally with teams such as Translational Drug Development, Biostatistics, Clinical Operations, Regulatory, Medical Affairs, and Commercial. Providing strategic and scientific leadership for both standard and novel trial designs, tailored for large and rare disease indications, will be a core function.
• Staying at the forefront of scientific literature and therapeutic area knowledge is essential to effectively communicate complex information about our products and candidates. You will act as a therapeutic area expert, providing scientific input into the development, execution, and communication of clinical trials. Maintaining a keen awareness of the external research and regulatory landscapes, and proactively tracking emerging study data, will ensure our clinical development plans and trial endpoints remain optimal.
• Building and nurturing relationships with KOLs and other external experts to gather scientific and medical input on clinical development topics will be a key aspect of the role. You will also be responsible for drafting and reviewing critical clinical and scientific sections of regulatory submissions, including INDs and NDAs, and preparing discussion documents for interactions with regulatory bodies and Health Authorities.
• The role involves drafting and reviewing essential study documents such as Investigator Brochures, clinical study protocols, clinical study reports, and regulatory submissions, as well as scientific publications including posters, abstracts, and manuscripts. You will actively participate in the interpretation of clinical trial data, providing expert insights into the clinical relevance of trial results.
• Furthermore, you will contribute to the analysis of development strategies and options for our discovery pipeline programs, offering input on Proof-of-Concept trials, biomarker strategies, and new research opportunities. Support for in-licensing and out-licensing activities, as well as partner relationships, will also be required.
• You will present proposals and strategic plans to diverse audiences, including Xenon’s Senior Executive Team. Contributing to the establishment of short- and long-term departmental goals, aligned with overall Company and Development strategies, is expected. You will also play a role in the planning and management of budget proposals and approved budgets, adhering to company financial policies.
• Acting as a clinical expert, you will provide scientific knowledge into the development, execution, and communication of global clinical trials. Close collaboration with external clinical vendors and other partners to ensure high-quality, high-integrity data generation, focusing on medical, scientific, and psychometric data quality expectations, reviews, and actions, is crucial.
• This role may require domestic and international travel. If applicable, you will recruit, lead, direct, develop, coach, and evaluate direct reports, ensuring adherence to company HR policies. All activities must be conducted in accordance with Company policies, including the Code of Business Conduct and Ethics.

🎯 Requirements

• MD or MD PhD with strong and versatile clinical development experience, ideally in psychiatry (preferably BPD), with neurology experience being a significant asset.
• Minimum 8-12 years of progressive development experience in the pharmaceutical industry or equivalent (e.g., regulatory agency, academic research), with the majority of relevant experience gained in an industry setting.
• Minimum 12 years of relevant management experience, or a combination of advanced degrees and experience, equating to an MD with at least 6 years of required relevant management experience.
• Comprehensive knowledge of pharmaceutical product development, product lifecycle management, and commercialization processes.
• Proven experience in developing clinical development study concepts and clinical trial designs with cross-functional input (including biostatistics, observational research, and patient-reported outcomes) across Phase 1, 2, and/or 3 clinical trials, with a requirement for experience from concept to clinical study report.
• In-depth understanding of Good Clinical Practices (GCP), FDA and EMEA CHMP regulations and guidelines, and applicable international regulatory requirements.
• Demonstrated growth mindset, leadership experience, and leadership potential as a clinical development expert and Medical Monitor within a complex matrix environment.
• Exceptional ability to effectively present ideas and articulate complex medical and clinical concepts both verbally and in writing.
• Strong interpersonal skills and advanced problem-solving abilities, exhibiting superior judgment and a balanced, realistic understanding of issues and their resolution pathways.

🏖️ Benefits

• Competitive compensation package including base salary, target bonus, and stock options.
• Comprehensive health benefits including medical, dental, and vision insurance.
• Robust insurance coverage including short-term and long-term disability, accidental death & dismemberment, and life insurance programs.
• Employee Assistance Program (EAP) for confidential support.
• Travel insurance for business-related trips.
• Retirement savings programs with generous company matching contributions.
• Generous paid time off including vacation, personal days, and sick days, complemented by an end-of-year company shutdown.
• Commitment to professional growth through an expanding Training, Learning & Development program, including Tuition Assistance for advanced degrees.

Skills & Technologies

GCP

REST

Senior

Remote

Degree Required

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Xenon

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About Xenon

Xenon is a leading provider of advanced data analytics and artificial intelligence solutions. The company specializes in developing and implementing cutting-edge technologies that help businesses unlock the full potential of their data. Xenon's offerings include predictive modeling, machine learning algorithms, and data visualization tools, all designed to drive informed decision-making and operational efficiency. They serve a diverse range of industries, including finance, healthcare, and retail, empowering clients to gain deeper insights, optimize performance, and achieve strategic business objectives. Xenon is committed to innovation and delivering tangible value through data-driven strategies.

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