Associate Director, CMC Development Programs (Hybrid/Remote)

Xenon Pharmaceuticals Inc.; Needham (MA); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Stock options

Medical, dental, vision benefits

Tuition assistance

Training & development program

Vacation and personal days

Job summary

Xenon Pharmaceuticals Inc. in Needham/Boston, MA, is seeking an Associate Director/Director of Development Program Management, CMC, to lead strategic and operational planning for CMC programs across early development.

The role partners with CMC and program teams to translate strategy into executable plans, maintain milestone trackers, dashboards, and risk logs, and drive governance. Hybrid work with some travel required; compensation includes base salary and stock options.

Qualifications

• Bachelor’s degree in a scientific, technical, business, or related discipline.
• 8+ years in biotechnology or pharmaceutical industry for Associate Director; 10+ years for Director.
• Experience in CMC, pharmaceutical development, or related drug development environments.
• Experience supporting small molecule drug substance/product development; API development preferred.
• Proven ability to influence across cross-functional teams and drive execution.
• Proficiency with Smartsheet, MS Project, and MS Office; PMP preferred.

Responsibilities

• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Lead project management for assigned CMC activities, including new molecules, tech transfer, scale-up, lifecycle management, and other development initiatives.
• Develop, baseline, and maintain project management tools and reporting, including CMC project plans, dashboards, milestone charts, action logs, risk logs, status reports, and financial tracking.
• Drive team execution and governance through effective meeting management, decision and action documentation, follow-up with accountable owners, and clear communication of progress, risks, issues, and key decisions.
• Monitor project progress, identify risks or execution gaps, and partner with stakeholders to develop mitigation plans, escalation recommendations, and decision-ready updates.
• Improve CMC project management effectiveness through scalable tools, templates, Smartsheet solutions, automation, AI-enabled approaches, and other process improvements.
• Act in accordance with Company policies, including 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.
• Other duties as assigned.

Skills

CMC project mgmt

Cross-functional leadership

Influence without authority

Stakeholder management

Education

Bachelor’s degree

Advanced degree preferred

Tools

Smartsheet

Microsoft Project

Microsoft Office

Job description

Xenon Pharmaceuticals Inc. in Needham/Boston, MA, is seeking an Associate Director/Director of Development Program Management, CMC, to lead strategic and operational planning for CMC programs across early development.

The role partners with CMC and program teams to translate strategy into executable plans, maintain milestone trackers, dashboards, and risk logs, and drive governance. Hybrid work with some travel required; compensation includes base salary and stock options.