Director or Senior Director Data Management

3 weeks ago

Vancouver BC, Canada Xenon Pharmaceuticals Inc. Full time

Director/Senior Director, Development Program Management
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures. In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 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.
We are seeking a Director/Senior Director, Development Program Management to lead and coordinate cross-functional planning of Xenon’s clinical-stage small-molecule drug development programs in both late and early phases with regulatory submissions experience (eg NDAs, MAAs) and life cycle management projects. This role involves close coordination with stakeholders within development (e.g., Clinical Development, Clinical Operations, CMC, Non-Clinical, Regulatory Affairs, QA) and outside of development (e.g., Finance, Commercial, Legal).
This position reports to the Executive Director, Development Program Management and will be in Vancouver, BC, Canada or Boston, MA, USA. Responsible for partnering with functional leaders and key stakeholders to lead the development, implementation and maintenance of high-quality integrated plans for multiple projects or programs addressing program scope, components, schedule, budget, communications, risks, staffing and change management.
Ensure cross-functional alignment and accountability on all aspects of program and proactively monitor timelines, milestones, critical path activities and resource needs for assigned programs and/or projects.
Support and facilitate resources and financial planning and assessments for programs including working directly with functional leads on assessment of resource timing across programs.
Proactively identify, articulate, escalate and manage program risks for program delivery through risk mitigation and scenario planning; collaborate with key stakeholders to recommend constructive solutions to the program team and senior management.
Create team charters and develop and maintain clear, concise and accurate dashboards for monitoring and communicating program progress to the program team and all levels of the organization, including supporting the development of presentations for Senior Management.
Chair, facilitate and coordinate program and/or project meetings and maintain decisions and action items for tracking to completion.
Identify cross-functional projects and/or program issues and resolve as applicable and communicate to Exec. Director Development Program Management and cross-functional Team Leads. Ensure regular and meaningful program communications, including establishing key metrics and monitoring performance, through dashboards and reports to enable timely information and analyses for senior leaders.
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, 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, if any.
Some international travel may be required.
10+ years of experience in small molecule drug development, including 8+ years of progressive and relevant project/program management experience from early phase clinical development through to registration and approval.
Strong understanding of the component drug development functions (Clinical Development, Clinical Operations, CMC, clinical pharmacology, Non-Clinical, Regulatory, QA) and industry best practices for drug development.
University degree in a relevant scientific field. Advanced degree (PhD; MSc plus MBA) strongly desired.
Experience working in GxP environments and quality and regulatory standards requirements for pharmaceutical industry.
Hands on functional experience in drug development (e.g., Demonstrate strategic thinking with ability to develop solid executable tactical plans with impeccable attention to detail.
Proficiency in using standard project management software (e.g., MS Project, Smartsheet) for building Gantt charts and maintaining timelines, and the Microsoft Office suite (i.e., PowerPoint, Word, Excel, SharePoint, etc.) Exceptional organizational and time management skills.
Project, Program, or Portfolio Management certification is preferred but not required.
The base salary range for this role is $172,600 to $244,500 CAD ; Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.


Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

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