Senior Director, Pharmacovigilance and Drug Safety, ...

Senior Director, Pharmacovigilance and Drug Safety, Risk Management and Safety Governance Boston, MA, USA Req #343 Thursday, February 20, 2025 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 a Senior Director, Pharmacovigilance and Drug Safety, Risk Management and Safety Governance , to join Xenon's department of Drug Safety and Pharmacovigilance (DSPV). This position will lead Xenon's risk management and safety governance strategy and operations by ensuring ongoing compliance with departmental procedures and global drug safety regulations throughout product lifecycle from First-in-Human (FIH) through post-marketing stages of development. The incumbent is responsible for fortifying a strong risk management infrastructure by developing, executing, and leading effective risk mitigation strategies for Xenon's clinical assets and future marketed products. The individual will author risk management documents, review relevant risk management sections of other documents, contribute to aggregate safety reports, and, when necessary, assist in responding to information requests from Health Authorities for Xenon products. This individual will participate in cross-functional Safety Governance meetings, provide guidance on industry best practices and regulatory requirements for risk management activities, and collaborate with colleagues in Clinical Development, Trial Operations, Regulatory Affairs, Medical Affairs, Clinical Pharmacology, Biostatistics & Programming, Quality Assurance, and Legal departments. This position communicates regularly with Xenon senior management regarding any risk identification, mitigation, or compliance finding that potentially impacts the benefit-risk profile of Xenon's clinical assets and marketed products. This position reports to the Senior Vice President, Pharmacovigilance and Safety Officer and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate's education and industry experience. RESPONSIBILITIES: Develop, execute, and lead effective risk evaluation, management and mitigation strategies. Together with lead safety physicians and safety scientists will contribute to proactive signal detection, ongoing benefit-risk analyses, safety monitoring and reporting activities for Xenon products across all stages of development. Support safety physicians and safety scientists with operational aspects of Safety Governance efforts and ensure continuous harmonized operations of the risk management activities. Work cross-functionally across all departments at Xenon to implement industry best practices intended to enhance compliance with risk management-related regulations. Write and maintain relevant SOPs and procedures in compliance with global risk management regulations and guidelines. Compile and/or review risk management-related information for aggregate safety reports in support of periodic safety data review meetings. Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities that may require risk management evaluation. Review potential and identified risks and contribute to the Safety Governance process as a Risk Management (RM) subject matter expert (SME). Contribute to risk management/risk mitigation-related documents for Xenon products throughout product lifecycle from FIH to post-marketing. Communicate information/updates on Risk Management Programs for GPV activities. Review Safety Management Plan and provide input to risk management related sections of clinical study documents. Engage with cross functional teams regarding the potential or identified risk(s) and provide expert guidance. Represent Pharmacovigilance in regulatory inspections and internal audits both locally and globally concerning risk management activities. Lead development of Risk Management documents (REMS, RMPs), updates/maintenance of expectedness guides. Ensure that Safety Governance Charters reflect all Risk Management responsibilities, timelines, deliverables mandated by regulators. As a RM subject matter expert (SME), contribute and review risk management and/or REMS related information in publications, training materials and marketing/sales pieces. Engage and participate in industry meeting forums, including discussions held by regulators. Participate in ad-hoc projects or assignments that require risk management input. In situations where enhanced risk identification, mitigation, monitoring, or reporting is required, contribute to the following: Lead development and implementation of REMS processes, documents, workflows, or training sessions. Report or respond to Health Authorities Information Requests related to risk management activities. Communication with FDA and business partners in close collaboration with Regulatory Affairs. Ensure adherence to REMS requirements and act where needed on REMS program's "Elements to Assure Safe Use" (ETASUs). Conduct vendor selection and contract negotiation/renewals according to company policies. Serve as a liaison between Xenon and its vendors, ensuring vendor compliance with REMS requirements. Direct internal groups and external vendors or consultants pertaining to the development of the REMS Assessment Reports (RAR). Ensure implementation of FDA-approved changes to REMS programs. Document Control: maintain electronic files for relevant DSPV documents on the Xenon SharePoint or shared drives. Act in accordance with Company policies, including the Code of Business Conduct and Ethics. Some international travel may be required. Other duties as assigned. QUALIFICATIONS: Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 12+ years of management & pharmaceutical industry experience in Drug Safety & Pharmacovigilance or MD with 8+ years of clinical experience and 6+ years of management experience. Experience authoring Risk Management Plans (RMPs), Risk Assessment Reports (RARs) and contributing to risk management sections of other regulatory safety reports. Prior experience with Regulatory Agency interactions. Skilled in signal detection process and managing safety information. Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management. Excellent verbal and written communication skills. Safety experience in the Neuroscience, Ophthalmology and Psychiatry therapeutic space is highly desirable. Time management skills with ability to prioritize to meet required deadlines. Ability to multitask and prioritize under tight deadlines. Ability to be flexible, adapt to change, and work independently. The base salary range for this role is $264,400 to $303,800 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, and life insurance programs. Xenon encourages time to rest and recharge 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. As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position. 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. #J-18808-Ljbffr

Created: 2025-03-08