Associate Director/Director, Development Program Management, CMC

Role: Associate Director/Director, Development Program Management, CMC at Xenon Pharmaceuticals, focusing on strategic and operational leadership for early-stage (Phase 1-2) CMC activities of small molecule therapeutics. Responsibilities include translating strategy into integrated project plans, managing budgets, overseeing technical transfer, scale-up, lifecycle management, and ensuring cross-functional alignment and risk mitigation. The role supports regulatory submissions, including INDs and IMPDs, with a focus on API development and solid oral dosage forms. Collaborates with CMC and program teams, enhancing project management practices with scalable tools, automation, and emerging technologies. Reports to SVP, Portfolio and Alliance Management, based in Boston with hybrid remote options; some international travel may be required. Qualifications: Bachelor’s in a scientific, technical, or related field; 8+ years (Associate Director) or 10+ years (Director) experience in biotech/pharma, especially in CMC, drug substance, or drug product development; experience supporting early-phase regulatory filings and late-stage submissions preferred. Skills include project management, influence in matrix teams, proficiency with tools like Smartsheet and MS Project, and strong communication. Certification such as PMP is a plus.