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Associate Director/Director, Quality, Regulatory

1 month ago

Boston, United States Xenon Pharmaceuticals Inc. Full time

Associate Director/Director, Quality, Regulatory & Supply Chain Information Systems

Boston, MA, USA

Req #256 Who We Are:

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

Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information Systems,

to join our team. This role will be the IT business partner for the Quality, Regulatory and Supply Chain functions and will be the primary point of contact on all topics related to IT. The

Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information System

will partner with these groups to develop and execute against a functional technology roadmap, support existing enterprise applications (e.g. MasterControl eQMS), design and build effective and compliant data flows, and ensure compliance with relevant regulations (e.g. GxP and 21 CFR Part 11). The successful candidate will facilitate the design and adoption of effective data governance and lifecycle management processes, including the design and adoption of new technology to support these practices as needed. The

Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information System

will play a central role in the company’s planned implementation of a new ERP system, in collaboration with functional colleagues and the Director, Enterprise Applications. The successful candidate will act as the primary point of contact for the designated user groups on all topics related to IT and will partner with colleagues in IT to resolve issues and deliver solutions. S/he will also ensure that IT-sponsored initiatives and standards are tailored to meet the needs of the QR&SC functions and are successfully adopted. This

Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information System

role is a hands-on position with the expectation that their team will expand over time as new systems are implemented and as the IT operating model evolves. During this period of rapid growth and evolution, the

Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information System

will be assigned additional responsibilities (beyond the core responsibilities described) based on company needs, the individual’s experience and expertise, and the availability of resources within IT. This position reports to the Senior Vice President, Information Systems and will be located in the Boston, MA, USA area. The level of the position will be commensurate with the candidate’s education and industry experience. RESPONSIBILITIES: Act as the IT owner for all QR&SC information systems and collaborate with functional system owners and colleagues in IT to evolve the support model based on the needs of the users and the overall IT strategy. Partner with key stakeholders in the QR&SC functions to develop and execute against a functional technology roadmap encompassing current and future systems to address existing pain points, maximize the usage and value of existing systems, and develop new capabilities as needed. Serve as the primary point of contact between the QR&SC functions and IT to resolve issues, align on processes and standards, and ensure awareness and alignment on key initiatives (function- or IT-sponsored). Ensure that IT standards and processes are tailored to meet the unique needs and capabilities of the QR&SC functions. Facilitate effective IT planning, governance, and project delivery as these processes evolve. Actively collaborate with other IT business partners to manage common or cross-functional requirements and project dependencies, and to ensure an effective enterprise approach to system planning and design. Collaborate with the Associate Director/Director, Data Architecture & Engineering to ensure effective and secure data exchange with external vendors and service providers, and to facilitate the design and adoption of effective data governance and lifecycle management processes and tools to control data lineage. Design, develop, and document effective data flows and integrations among systems to enable efficient processes and workflows (including automation) and effective reporting and analytics. Collaborate with functional stakeholders and with the Quality department to ensure relevant systems are built and maintained in compliance with regulatory requirements and internal policies and procedures. Manage vendor relationships (e.g. software and service providers) in the context of both project delivery and ongoing operations to maximize value to Xenon. As a member of the IT Leadership Team, contribute to the development and execution of the strategy to evolve the overall IT operating model, including new structure, processes, and ways of working. 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. 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. Other duties as assigned. QUALIFICATIONS: Minimum undergraduate degree in Computer Science, Informatics, or related discipline. At least 8 years of progressive information technology experience in a similar role, with at least 3 years in a leadership/management role. Demonstrated ability to set direction and lead while simultaneously performing hands-on work. Experience working in a regulated environment including extensive knowledge of system validation requirements and frameworks. Domain knowledge of the work performed with the Quality, Regulatory & Supply Chain functions, including the ability to effectively collaborate with functional stakeholders. Proven ability to diagnose and solve problems, and to identify opportunities to more effectively leverage technology and data to drive agility, efficiency, insights, and compliance. Broad knowledge base of cloud technology offerings as they relate to life sciences. Excellent written and verbal communication skills with the ability to explain highly technical information in a concise and effective manner to an audience of varying technical aptitude. Strong interpersonal skills that support quickly building rapport with IT colleagues, functional stakeholders, and external vendors; ability to manage competing interests in a professional, collaborative and solution-driven manner. Ability to work flexibly in a fast-paced environment with a strong work ethic and positive attitude. Demonstrated ability to lead continuous improvements in development processes and practices. The base salary range for this role is

$158,100 to 222,800 USD ; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity. 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.

US positions only:Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here

. To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

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