Vice President, Trial Operations

7 months ago

Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

**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 epilepsy 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. 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. 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 Vice President, Trial Operations to join our team. The Vice President, 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 XEN1101 and future development compounds. The Vice President is responsible for ensuring studies (Phase I-IV) within a program and across Xenon’s portfolio 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 Vice President directly leads, manage, coaches and mentors staff in Trial Operations and Document Management.
The Vice President, 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.

**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.
- Manage study budgets, work closely with Outsourcing, Contracts and Finance to track and report performance against Statement of Work and budget.
- 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 collaborate with other Clinical Development staff in providing clinical project management support and the completion of assigned activities related to multiple clinical projects including timelines and budget management, CRO/vendor oversight, and risk-based monitoring strategies.
- Lead and manage Document Management staff and function, ensuring eTMF compliance and standards are aligned across our portfolio.
- 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 em

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