Senior Vice President, Regulatory Affairs

Boston, MA, USA ● Vancouver, BC, Canada Req #149
Thursday, November 24, 2022
Who We Are:  
 
At Xenon Pharmaceuticals (NASDAQ:XENE), we are committed to providing a brighter future for patients suffering from neurological disorders. Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver innovative medicines 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 pipeline of neurology-focused therapies, with a focus on commercializing novel treatments for epilepsy. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 Phase 3 program includes studies in adult patients with focal onset seizures and primary generalized tonic clonic seizures. In addition, XEN1101 is being evaluated as a treatment for major depressive disorder in both a company-sponsored Phase 2 clinical trial, as well as an investigator-led proof-of-concept study. Xenon's proprietary, pediatric formulation of ezogabine, XEN496, is being studied in a Phase 3 clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, where many innovative, early-stage research programs are underway. In addition to these proprietary programs, our pipeline includes clinical-stage partnered programs with valued collaborators. 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. 

About the Role: 
We are seeking a Senior Vice President, Regulatory Affairs to join our team. The Senior Vice President 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 Senior Vice President will interact with all levels of internal staff as well as external stakeholders, including the FDA, EMA, other health authorities and Advisory Boards. 
 
This position reports to the Executive Vice President, Research and Development Operations and will be located in either the Vancouver, BC, Canada or 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 of 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, CMC, and commercial throughout product life cycle 
  • Act as subject matter expert in interactions with key stakeholders including Company’s Board of Directors, Key Opinion Leaders, Advisory Boards and Committees and potential partners
  • Lead health authority interactions and discussions on key topics such as labeling and post marketing requirements and commitments 
  • Provide guidance for managing regulatory inspections and appropriately responding to inquiries and observations
  • Identify key regulatory issues, trends, and risk assessments for senior management and proactively develop and recommend appropriate strategies and plans
  • Oversee optimization and implementation of systems, processes and procedures to scale and optimize the Regulatory function in accordance with overall business strategies and plans 
  • Develop and propose short and long term objectives for the function in accordance with overall Company strategies and plans
  • Plan and manage budget proposals and approved budgets 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
  • 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 late stage global regulatory strategy to NDA and approval essential
  • Expert understanding of ICH guidance and global 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
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.