Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders.

At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.

Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us. We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon. To learn more about job opportunities at Xenon, please visit www.xenon-pharma.com.

We are seeking an Executive Director, Trial Operations to join our team. The Executive Director, Trial Operations will be a key member of a highly collaborative Clinical Development team responsible for developing strategies and plans for our portfolio of clinical stage assets, with particular focus on global phase 3 programs for XEN496 and XEN1101.  The Executive Director is responsible for ensuring studies (Phase I-IV) within a program are initiated, recruited, managed, and closed in accordance with Xenon’s overall program goals and timelines and in compliance with Xenon’s procedures, FDA regulations, GCP ICH requirements and other applicable regulations.

The Executive Director, Trial Operations will have proven leadership ability in a fast paced, multi-location environment and interact with all levels of internal staff, as well as external stakeholders, including, but not limited to CRO’s, Key Opinion Leaders and Advisory Boards and Committees. This is an excellent opportunity for someone with the ability to plan and execute at the program level and to lead, coach and mentor a growing team.

Reporting to the Senior Vice President, Clinical Operations, this position will be located in the Vancouver area, BC, Canada or the Boston area, MA, USA; we may consider other locations for an exceptional candidate.

RESPONSIBILITIES:

• Provide Clinical Operations leadership to support the design, development, execution, and delivery of clinical programs in accordance with Clinical Development Plans and timelines; closely collaborate with Clinical Development, Biostatistics, Data Management, Regulatory, Medical Writing, Medical Affairs, Supply Chain, and Development Program Management to ensure highly integrated cross functional project plans for programs and trials.
• Develop and implement plans (including resourcing strategy, budgets, and timelines) for clinical programs, studies, and activities; develop and track against KPI’s; anticipate potential program/study issues and prepare contingency plans; manage escalation of program and/or study related issues as appropriate with senior management and other R&D functions.
• Lead in the selection and oversight of CRO and/or functional service provider activities and other clinical vendors to ensure study quality meets the Company’s and regulatory requirements including preparing Requests for Proposals, facilitating the evaluation of the proposals and the selection and management of clinical service providers.
• Oversee and/or assist in all aspects of trial planning and execution, including, for example, the development of clinical trial protocols, consent forms, case report forms, study plans, and other essential regulatory documents, the selection of qualified investigators and study sites, and conduct and close-out of the trial.
• Lead and manage Clinical Trial Managers and other Clinical Development staff in providing clinical project management support and the completion of assigned activities related to multiple clinical projects including budget management, CRO/vendor oversight, and risk mitigation.
• Evaluate new technologies to leverage clinical trial lifecycle efficiencies such as Risk-Based Quality Management (RBQM), centralized statistical monitoring, patient recruitment, e-Source, and other emerging technology platforms; prepare proposals for new technologies selection and implementation in accordance with the Company’s Information Systems strategy.
• Work with all relevant groups (internal and external) to ensure all assigned activities are managed appropriately.
• Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice.
• Provides leadership in the development and implementation of risk-based monitoring strategies and CRA performance oversight.
• Develop and maintain relevant Standard Operating Procedures and other policies, procedures, and systems relevant to the department; collaborate with Quality to plan and execute compliant activities and other continuous improvement initiatives.
• Develop and propose short- and long-term goals for the program(s) in accordance with overall Company and Development and Commercial strategies.
• 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, if any, 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.

QUALIFICATIONS:

• Minimum of bachelor’s degree with a minimum of 15 years management experience in a pharma or biotech environment, ideally additional experience in neuroscience.
• Deep and broad experience in all aspects of Phase 1 to 3 global clinical trial design and execution.
• Experience in CRO selection, contracting and relationship management.
• Excellent working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company.
• Proven ability to build and develop high performing teams, excellent delegation, and conflict resolution skills.
• Be science and data driven while at the same time, creative and flexible in strategic thinking and problem solving.
• Ability to travel up to 15%, both domestically and internationally.

To apply for this position, click here, select Apply Now, and 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.