Associate Director Or Director, Cmc

Who We Are:

At Xenon Pharmaceuticals (NASDAQ:XENE), we are committed to providing a brighter future for patients suffering from neurological disorders. Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver innovative medicines 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 pipeline of neurology-focused therapies, with a focus on commercializing novel treatments for epilepsy. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 Phase 3 epilepsy program includes studies in adult patients with focal onset seizures and primary generalized tonic clonic seizures. In addition, XEN1101 is being evaluated as a treatment for major depressive disorder in both a company-sponsored Phase 2 clinical trial, as well as an investigator-led proof-of-concept study. We are also proud of the leading-edge science coming out of our discovery labs, where many innovative, early-stage research programs are underway. In addition to these proprietary programs, our pipeline includes clinical-stage partnered programs. 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, CMC to join our CMC team. The incumbent will be responsible for managing Xenon’s GMP and non-GMP analytical, synthesis and preformulation contract research organizations (CROs) as well as coordinating preformulation activities performed internally and externally.

The incumbent will serve as the main Xenon contact for our analytical, process development and preformulation CROs, with whom Xenon has both full-time equivalent (FTE) and fee-for-service (FFS) arrangements. The incumbent will provide scientific input and ensure that the CRO activities are aligned with project and program priorities, and that milestones such as regulatory filings and the availability of development reports are met. The incumbent will establish and track KPIs and progress against agreed-to work plans for our analytical, process development and preformulation CROs.

The incumbent will also contribute to the review of relevant documents such as, quality-related documents, relevant sections of regulatory filings, and preformulation development reports. Working in close collaboration with the rest of the CMC team (Drug Substance, Drug Product, CMC Quality Control, Analytical Development and Process Chemistry) as well as with other internal stakeholders (such as Discovery, QA, Regulatory Affairs, and Supply Chain Management), the incumbent will also monitor risks related to deliverables and propose appropriate mitigation activities.

This position reports to the Senior Director, CMC and will be located in either the Vancouver, BC, Canada or Boston, MA, USA location; we may consider other locations for an exceptional candidate. The level of the position will be commensurate with the candidate’s education and industry experience. Relocation and immigration support will be provided, if required.

RESPONSIBILITIES:

• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Ensure that appropriate stability data are obtained for candidate formulations.
• Perform ongoing vendor management, monitor vendor performance and track relevant vendor KPIs.
• Manage processes for vendor identification, selection, and start-up/onboarding.
• 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.
• Work effectively across cross-functional areas, including but not limited to Discovery, CMC Drug Product, CMC Drug Substance, Analytical Chemistry, Quality Assurance, Regulatory Affairs, Technical Writing, and Process Chemistry.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Contribute to the review of relevant documents such as quality-related documents, and development reports.
• Manage preformulation activities including physicochemical and solid-state properties for investigational small molecules such as solubility, solid state stability, particle size and morphology, bio-relevant dissolution, polymorphism, and excipient compatibility.
• Contribute to the drafting and/or review of relevant sections of Xenon’s regulatory filings
• Devise, refine, and communicate work plans in order to ensure that Xenon’s CROs/CDMO partners remain aligned with project and program priorities.
• Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.)
• Work with Development Program Management to proactively build detailed CMC timelines providing technical clarity, project risks, resourcing and decision points.
• Other duties as assigned.
• Some international travel may be required.

QUALIFICATIONS:

• Project management experience and/or certification (e.g., CAPM, PMP) would be considered an asset.
• Demonstrated track record of successfully managing CRO or other external resources while ensuring adherence to agreed-to budgets, quality standards and timelines.
• Ability to be flexible, adapt to change, work independently, as well as experience working in a matrix environment.
• Excellent verbal and written communication skills with ability to write clearly and concisely, and strong presentation skills.
• Experience with tools to analyze salt and polymorph forms: particle size analyzers, dissolution instruments, XRPD, DSC, TGA, KF, DVS, PLM, NMR, and SEM.
• Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment.
• M.Sc. or Ph.D. degree in analytical chemistry or organic chemistry.
• Thorough understanding of current Good Manufacturing Practices (cGMP) principles, guidance documents and regulations pertinent to the preformulation and characterization for new active pharmaceutical ingredients and drug products in the Xenon development pipeline.
• Sound time management skills with ability to prioritize to meet required deadlines.
• 10+ years of experience in pharmaceutical (small molecule) development and in a company and/or CRO setting with experience working at all stages of development from discovery to late stage, including method validation for product commercialization.