Senior Director/Executive Director, Program Management, CMC

We are seeking a Senior Director/Executive Director, Program Management, CMC to join our team.  Working in close collaboration with both cross-functional program teams, with emphasis on CMC and Regulatory functions, the incumbent will lead the translation of CMC program strategies into concrete deliverables and integrated timelines, maintain and communicate key project documents (project plans, risk registers, action items, etc.), and provide team support through validation and commercial launch.  As the first CMC Program Management hire, you have the opportunity to help define and shape what excellent program management will look like at Xenon and across our development programs. 

This position reports to the Senior Vice President, Portfolio and Alliance Management and will be in Vancouver, BC, Canada or Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. This role is a hybrid position, requiring a minimum of 2 days per week in the office.

RESPONSIBILITIES:

• Align inter-dependent functions to achieve defined goals and milestones
• Develop, refine, update, and oversee CMC project plans from multiple inputs, with emphasis on the alignment of these plans with strategic objectives, the decomposition of major objectives into discrete WBS-level work packages, the mapping of internal and cross-functional interdependencies, and the management of project risks
• Perform detailed scenario planning where significant ambiguity is present and map out the scope, cost, timeline, and risk aspects of each scenario
• Monitor and report on progress against these plans, including resource monitoring, critical path analysis, the establishment and tracking of vendor KPIs, and financial performance
• Produce clear and concise materials for presentations to program teams and Senior Management
• Maintain and manage comprehensive risk registers for assigned CMC programs, including risk responses
• Organize and facilitate team meetings, track action items and help ensure their timely completion
• Serve as a primary cross-functional point of contact for CMC project-related communications with both internal (e.g., Quality, Regulatory, Discovery, Supply Chain) and external (CDMOs, partners) stakeholders
• Propose enhancements to our project and program management processes 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
• Other duties as required from time to time

QUALIFICATIONS:

• MSc or PhD in a relevant technical/scientific discipline along with a minimum of 12+ years of pharmaceutical/biotechnology industry experience, including at least 4 years of direct CMC project management experience
• PMP certification, as well as experience with small molecule API and solid oral dosage forms, are desired
• A sound understanding of CMC development strategies across all phases of development, including regulatory submissions.  IND, NDA/MAA, IMPD submission experience with a strong track record of success.
• Thorough knowledge of contemporary project management techniques and best practices in project planning, monitoring, reporting and close-out
• A strong track record of cross-functional collaboration with both technical and non-technical stakeholders
• Strong analytical skills along with a proven ability to facilitate issue resolution in a fast-paced environment
• Excellent oral and written communication skills
• Proficiency with Microsoft Project, SmartSheet and Microsoft Office

The base salary range for this role is $243,000 to $307,300 CAD / $257,200 to $311,500 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.