Associate Director / Director, Trial Operations

Who 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. 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 an Associate Director or Director, Trial Operations, to join our team. The Associate Director or 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 Phase 2 and Phase 3 global studies. The Associate Director or Director is responsible for ensuring studies across 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. This incumbent will also lead a team of Trial Managers and Associates.

The Associate Director or 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.

This position reports to the Vice President, Trial Operations will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. For Boston based candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office.
RESPONSIBILITIES:
• Provide Trial Operations leadership across multiple studies to support the design, development, execution, and delivery of clinical programs in accordance with Clinical Development Plans and timelines for assigned program area; 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.
• 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
• Collaborate with cross-functional team members to ensure highly integrated plans and documents for clinical trials.
• Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice.
• Develop and propose short- and long-term goals for the program(s) in accordance with overall Company and Development and Commercial strategies.
• 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 contributing to the preparation of Requests for Proposals, facilitating the evaluation of the proposals and the selection and management of clinical service providers.
• Lead, plan and manage budget proposals and approved budgets in accordance with the Company’s strat