Director/Senior Director, Trial Operations

We are seeking a Director or Senior Director, Trial Operations to join our team. The Director/Senior 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 XEN1101 and Phase I trials.  The Director/Senior Director is responsible for ensuring studies 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. This incumbent will also lead a team of Trial Managers and Associates.
 
The Director/Senior 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 and will be in Boston, MA, USA. The level of the position will be commensurate with the candidate’s education and industry experience.

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; 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.
• 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.
• Develop and propose short- and long-term operating 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 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.
• 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.
• 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.
• Lead and contribute to the development of department initiatives including developing and maintaining relevant Standard Operating Procedures and other policies, procedures, and systems relevant to the department; collaborating with Quality to plan and execute compliant activities and other continuous improvement initiatives.
• 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.
• 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, if any.
• Some international travel will be required
• Other duties as assigned

QUALIFICATIONS

• Minimum bachelor’s degree with at least 12 years’ management experience in a pharma or biotech environment, ideally more 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.

The base salary range for this role is $197,500 to $275,600 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.