Senior Director/Executive Director of Analytical Development and Regulatory Compliance

2 weeks ago

Vancouver, British Columbia, Canada Xenon Pharmaceuticals Inc. Full time
About Xenon Pharmaceuticals Inc.

Xenon Pharmaceuticals Inc. is a premier neuroscience company that is advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression.

We are building upon the positive results and compelling data from our Phase 2b study in adult patients with focal epilepsy, and our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures.

In addition, we are proud of the leading-edge science coming out of our discovery labs, which leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.

Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications.

We are seeking a Senior Director/Executive Director, Analytical Development and Regulatory Compliance to join our CMC team. The incumbent will be responsible for leading a team of analytical development scientists and external FTEs and for ensuring that robust analytical methodology is developed and validated to support the advancement of the Company's portfolio of APIs and drug products.

This position reports to the Vice President, Product Development & Operations and will be located in Vancouver, BC, Canada. Relocation and immigration support will be provided, if required.

Key Responsibilities:
  • Lead the CMC Analytical Development function, which is accountable for developing, updating and validating all release and stability analytical methods for drug substance and drug product.
  • Collaborate closely with Quality Control and Quality Assurance to ensure the timely GMP release of drug substance and drug product lots.
  • Serve as a contributor and subject matter expert (SME) for analytical aspects of the Company's regulatory filings.
  • Effectively manage the Company's external contract analytical testing and method development partners.
  • Develop and maintain relevant Standard Operating Procedures and other policies, procedures and systems pertaining to the department.
  • Maintain current knowledge of issues relevant to drug development, Competent Authority regulations and guidance, as well as industry trends.
Requirements:
  • Extensive knowledge of cGMP-related regulations, guidance, principles and best practices pertinent to the testing of both drug substances and drug products in both development and commercial contexts.
  • Strong track record of developing, validating and defending dissolution methods for solid oral dosage forms.
  • Experience managing projects and FTEs at GMP testing CROs.
  • The ability to be science- and data-driven while at the same time creative and flexible in strategic thinking and problem solving.
Compensation:

The base salary range for this role is $193,000 to $259,100 CAD per year. 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- and long-term disability, accidental death and dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

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