Director​/Senior Director, CMC, Drug Substance

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 look for people who thrive in a respectful, collaborative, inclusive, and productive culture.

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 is a clinically validated potassium channel modulator in late‑stage development for multiple indications. Other clinical programs target major depressive disorder, bipolar depression, and acute pain, with Phase 1 studies underway for XEN
1701 and XEN
1120.

We are seeking a Director/Senior Director, CMC, Drug Substance to manage and oversee the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for late‑stage clinical trials and ultimately for commercial use. The position reports to the Executive Director, CMC, Drug Substance and is based in Needham, MA, with hybrid work required (minimum 2 days per week in the office).

Outstanding remote candidates will be considered.

• Manage and oversee the development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards.
• Evaluate, recommend, and manage qualified CDMOs for the manufacture of API for clinical trials and for commercial use.
• Serve as the subject‑matter expert and participate in audits and inspections of API CDMOs in conjunction with Quality Assurance.
• Collaborate closely with the internal process chemistry team to transfer API process technology to CDMOs, including process validation and specification refinement.
• Work closely with Supply Chain and CMC Drug Product colleagues to translate clinical and commercial demand forecasts into API manufacturing plans.
• Author (with Technical Writing) and/or review core CMC documents/modules for FDA and other regulatory authorities.
• Provide strategic oversight for regulatory interactions, including IND/NDA/MAA/IMPD filings and periodic updates.
• Plan and manage API‑related budgets in alignment with the company’s strategic plans and Finance policies.
• Recruit, lead, develop, coach, and evaluate direct reports in accordance with human resource policies.
• Develop and propose short‑ and long‑term objectives for the function in line with company strategy.
• Act in accordance with company policies, including the Code of Business Conduct and Ethics, ensuring compliance by direct reports.
• Travel internationally as required.
• Perform additional duties as assigned.

• PhD in Chemistry, Chemical Engineering, or a related discipline with a minimum of 10 years of directly‑related experience in a pharma or biotech environment; MSc candidates with significant experience may also be considered.
• Demonstrated track record in successfully managing development‑stage and/or commercial‑stage API manufacturing activities at CDMOs.
• Experience authoring or co‑authoring key CMC sections in U.S. NDA and European MAA filings for small‑molecule APIs.
• Extensive knowledge of cGMP‑related regulations, guidance documents, principles, and best practices pertaining to APIs.
• Experience with CDMO selection, vendor management, contracting, issue resolution, and management.
• Excellent written and oral communication skills, including the ability to communicate with scientific and non‑scientific personnel and to apply risk‑based decision‑making tools.
• Strong interpersonal and team skills to work independently and collaboratively within a multidisciplinary team.
• Attention to detail and commitment to high‑quality work.
• Strong organizational skills and the ability to manage multiple competing priorities.
• A science‑ and data‑driven mindset, combined with creative and flexible strategic thinking.

Our Total Rewards program includes a base salary, target bonus, and stock options, as well as a full range of benefits: medical, dental, vision, short‑ and long‑term disability, accidental death & dismemberment, life insurance, an Employee Assistance Program, travel insurance, and retirement savings with company match. Xenon encourages rest and recharge through vacation, personal days, sick days, and an end‑of‑year shutdown.

The company offers a robust Training, Learning & Development program, including tuition assistance for advanced degrees.

Compensation Range: $222.3K - $302.9K