Executive Director, CMC, Drug Product

Who We Are:


Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. 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 and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. 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 Executive Director, CMC, Drug Product to join our team. The Executive Director, CMC, Drug Product manages and oversees the development and manufacturing of cGMP drug products for deployment in early- and late-stage clinical trials and commercial distribution. The Executive Director, CMC, Drug Product will be a key member of a highly collaborative internal CMC team, primarily managing programs and manufacturing campaigns through CDMOs and CROs.
This position reports to the Senior Vice President, Pharmaceutical Sciences and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. This role is a hybrid position, requiring a minimum of 2 days per week in the office
RESPONSIBILITIES:
• Lead teams in formulation development, and manufacturing of small molecule drug products from preclinical stages through NDA approval and commercialization.
• Oversee development and manufacturing processes, ensuring compliance with quality and regulatory standards.
• Manage R&D activities related to preformulation, solid form, formulation, and drug product processes, including technology transfer through CDMOs or internal resources. This includes process validation and proposing specifications for excipients and finished drug products, as well as contributing to analytical method development.
• Integrate preformulation and biopharmaceutics strategies within CMC to facilitate early candidate selection.
• Develop and implement formulation strategies for poorly soluble small molecules using techniques such as particle size reduction, lipid-based formulations, amorphous solid dispersions, and self-emulsifying drug delivery systems.
• Provide input for drug product stability programs and select appropriate packaging for clinical development and commercial use.
• Evaluate, recommend, and manage qualified CDMOs for manufacturing drug products for clinical trials, scale-up, validation, and commercial use. Collaborate with Quality Assurance to manage audits and inspections of CDMOs.
• Author and review core CMC documents/modules and other submissions and responses to FDA and other Competent Authorities, ensuring strategic oversight and consistency for regulatory interactions, including IND/NDA/MAA/IMPD filings and periodic updates.
• Stay informed on pharmaceutical development, regulatory guidelines, and competitive trends to provide informed recommendations.
• Develop and propose short- and long-term objectives for the function in alignment with overall company strategies and plans.
• Collaborate with development and commercial partnerships, including ex-US collaborations, to ensure global alignment and integration of strategies.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
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