Director, CMC Development Program Mgmt (Hybrid/Remote)

Xenon Pharmaceuticals; Needham (MA); Hybrid; USD 160,000 - 230,000; Full time

Benefits offered by this job

Medical, dental, vision

Stock options

Tuition Assistance

Retirement savings with company match

Vacation and company shutdown

Job summary

Xenon Pharmaceuticals in Boston, MA (Needham office) seeks an Associate Director/Director, Development Program Management, CMC to lead strategic and operational PM for CMC programs, focusing on early-phase compounds and tech transfer. The role partners with CMC and program stakeholders to translate strategy into actionable execution plans, dashboards, and risk logs.

You will build robust project plans, manage budgets, drive governance, and support IND/IMP submissions.

Qualifications

• Bachelor's degree in a scientific, technical, business, or related discipline is required.
• 8+ years in biotechnology/pharma, at Associate Director level, or 10+ years at Director level; CMC/ development exposure.
• Experience with small molecule drug substance/product development; API development and solid oral dosage forms preferred.
• Experience managing cross-functional CMC deliverables, timelines, risks, and regulatory support.
• Proven ability to influence and align stakeholders; execution discipline in complex teams.
• PMP or equivalent project management training is preferred.

Responsibilities

• Plan and manage budgets and translate strategy into integrated CMC execution plans.
• Lead project management for CMC activities including molecules, tech transfer, scale-up, and lifecycle management.
• Develop and maintain CMC project plans, dashboards, milestone charts, and risk logs.
• Drive governance and meeting efficiency with clear decisions and owner follow-up.
• Monitor progress, identify risks, and propose mitigations and updates for stakeholders.
• Improve PM practices using scalable tools, automation, and AI-enabled approaches.
• Ensure compliance with company policies and ethics; travel as required.
• Other duties as assigned.

Skills

PM leadership

Cross-functional coordination

Communication

Education

Bachelor's degree

Advanced degree preferred

Tools

Smartsheet

Microsoft Project

Microsoft Office

Job description

Xenon Pharmaceuticals in Boston, MA (Needham office) seeks an Associate Director/Director, Development Program Management, CMC to lead strategic and operational PM for CMC programs, focusing on early-phase compounds and tech transfer. The role partners with CMC and program stakeholders to translate strategy into actionable execution plans, dashboards, and risk logs.

You will build robust project plans, manage budgets, drive governance, and support IND/IMP submissions.