Associate Director/Director, Development Program Management, CMC

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

Who We Are:

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

What We Do:

We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for pain. 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.

About the Role:

We are seeking an Associate Director/Director, Development Program Management, CMC to join our team. The Associate Director/Director, Development Program Management, CMC will provide strategic and operational project management leadership for CMC teams, with an initial focus on phase 1 and 2 compounds. This role will drive integrated planning, execution support, governance, and communication across multiple cross-functional programs and initiatives.

The successful candidate will partner closely with CMC and program stakeholders to translate strategy into clear, actionable execution plans; maintain high-quality project plans, dashboards, milestone trackers, risk and action logs; and ensure timely follow-up on key deliverables, decisions, dependencies, and risks. The role will also help strengthen project management practices through scalable tools, clear meeting governance, financial tracking, continuous improvement, and appropriate use of emerging technologies.

This position reports to the Senior Vice President, Portfolio and Alliance Management and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week.

RESPONSIBILITIES:

• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies. Partner with CMC, Development Program Management, Program Team Leaders, and functional stakeholders to translate program strategy into integrated CMC execution plans, project charters, and team ways of working for assigned programs and initiatives.
• Lead project management for assigned CMC activities, including new molecules, tech transfer, scale-up, lifecycle management, and other development initiatives, ensuring alignment of scope, timelines, milestones, dependencies, deliverables, and risks.
• 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, as appropriate.
• 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 that enhance planning, visibility, and execution.
• 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.
• Other duties as assigned.

QUALIFICATIONS

• Bachelor’s degree in a scientific, technical, business, or related discipline required; advanced degree preferred.
• Typically requires 8+ years of relevant biotechnology or pharmaceutical industry experience for Associate Director level, or 10+ years for Director level, including significant experience in CMC, pharmaceutical development, technical operations, or related drug development environments.
• Experience supporting small molecule drug substance and drug product development required; experience with API development and solid oral dosage forms strongly preferred.
• Demonstrated experience managing cross-functional CMC deliverables, timelines, risks, and documentation in support of early-stage regulatory submissions, including INDs and/or IMPDs; exposure to NDA/MAA or other late-stage submission activities preferred.
• Proven ability to influence without authority, drive alignment across technical and non-technical stakeholders, and ensure execution discipline across complex, matrixed development teams.
• Experience developing and maintaining CMC-specific project plans, dashboards, milestone charts, action logs, risk logs, and related project management tools.
• Strong analytical, facilitation, problem-solving, written communication, and verbal communication skills, with the ability to communicate effectively with both technical and non-technical stakeholders.
• Proficiency with Smartsheet, Microsoft Project, Microsoft Office, and related project management tools required.
• PMP certification or equivalent project management training preferred.

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 encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.