Vice President, Regulatory Affairs (Clinical)

Company: xenon-pharma
Location: Boston
Posted on: April 22, 2025

Job Description:

Vice President, Regulatory Affairs (Clinical)Boston, MA, USA Req #334Tuesday, February 11, 2025Who We Are:Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. 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 and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.About the Role:We are seeking a Vice President, Regulatory Affairs (Clinical) to join our team. The Vice President, Regulatory Affairs (Clinical) will establish and manage global regulatory strategy and operations for the Company's product pipeline from early and late-stage development through registration and post-approval activities. The Vice President will interact with all levels of internal staff as well as external stakeholders, including the FDA, EMA, and other health authorities, Advisory Boards, partners and potential partners.This position reports to the Senior Vice President, Regulatory Affairs and will be located in Boston, MA, USA location; we may consider other locations for an exceptional candidate.RESPONSIBILITIES:

• Develop, propose and implement global regulatory strategies for development of the Company's portfolio of products and product candidates from discovery through development and commercialization in alignment with corporate strategy.
• Provide leadership and oversight for the preparation of all critical global regulatory submissions (from INDs to marketing applications) to the FDA, EMA, and other health authorities.
• Provide strategic and technical regulatory guidance and direction to cross-functional team members in non-clinical, clinical, and commercial throughout product life cycle.
• Effectively oversee the planning, organization, preparation, and conduct of formal meetings with health authorities and lead discussions on key topics such as labeling and post marketing requirements and commitments.
• Assure compliance with project team timelines and milestones.
• Provide guidance for managing regulatory inspections and appropriately responding to inquiries and observations.
• Identify key regulatory issues, trends, and risk assessments for Xenon's development programs and proactively develop and recommend appropriate strategies and plans.
• Develop and propose short- and long-term objectives for the Regulatory Affairs, Clinical and Regulatory Affairs, Operations functions in accordance with overall Company strategies and plans.
• Plan and manage budget proposals and approved budgets for the Regulatory Affairs, Clinical and Regulatory Affairs, Operations Functions in accordance with the Company's strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports, in accordance with the Company's Human Resource policies and practices.
• Reward and recognize employees who take initiatives beyond expectations to advance business goals.
• 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.
• Some international travel may be required.
• Other duties as assigned.QUALIFICATIONS:
  • Master's degree in a Life Sciences discipline with relevant regulatory training and certifications.
  • Minimum of 15 years of Regulatory leadership roles of increasing responsibility with small and large multi-national biopharma companies; neurology experience, specifically epilepsy, highly desirable.
  • Experience in all phases of global drug development from pre-IND through NDA and post-licensure; experience leading latestage global regulatory strategy to NDA submission and approval essential.
  • Comprehensive understanding of global regulations and regulatory processes.
  • Strong interpersonal and leadership skills to work both independently and collaboratively as part of multidisciplinary teams in a fast-paced, distributed and highly matrixed environment.
  • Demonstrated experience in building regulatory teams, systems and processes appropriate to scale.
  • Excellent interpersonal, verbal and written communication skills.
  • Able to work independently under tight timelines and be willing to contribute significantly to day-to-day operations as needed.The base salary range for this role is $315,000 to $350,000 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.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.US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
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Keywords: xenon-pharma, Hartford , Vice President, Regulatory Affairs (Clinical), Healthcare , Boston, Connecticut