Job Description

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 or Executive Director, Pharmacovigilance and Drug Safety, Operations and Systems to join our team. The incumbent will play a key leadership role in Drug Safety and Pharmacovigilance, building Pharmacovigilance Operations, Systems and Compliance team, supervising and mentoring PVO and compliance staffs, responsible for all PV operations, systems and compliance aspects of all Xenon's products throughout the product lifecycle (from First-In-Human to post-marketing), providing strategic leadership in safety surveillance for Xenon's clinical development programs pre- and post-launch, and ensuring corporate compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management of Xenon products. This individual will build PV infrastructure and processes for case management and reporting, aggregate safety reporting, Global Safety Database, PV system, vendor oversight, compliance, inspection readiness, launch readiness, budget, contracts and training.

This position reports to the Senior Vice President, Pharmacovigilance and Safety Officer, and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. For Boston based candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office.

RESPONSIBILITIES:

• Build, manage and mentor PV Operations and Compliance team.
• Responsible for all PV operation and compliance aspects of all Xenon's products throughout the product lifecycle from First-In-Human to post-marketing.
• Maintain Xenon's Global Safety Database (GSBD) and generate reports/LLs from GSBD for Safety Signal Assessment Reports and Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Reports (PADER), IND Annual Safety Reports, and responses to health authorities' requests for safety information.
• Build and implement pharmacovigilance systems compliant with global PV regulations.
• Responsible for ICSR case processing and reporting, and aggregate safety reporting.
• Manage the process for identifying, evaluating, and selecting outsourcing safety vendors.
• Provide vendor oversight for all outsourced PV activities, including establishing and monitoring key quality and compliance metrics.
• Responsible for PV Agreement/Safety Data Exchange Agreement with license partners and distributors.
• Responsible for PV operation related inspections by competent authorities, vendor/partner audits, contributing to investigation of deviations and CAPA execution, etc.
• Build PV infrastructure, PV system and PV process for inspection readiness and launch readiness in compliance with global safety regulations and guidelines.
• Responsible for development and training of all PV operations, systems and compliance related SOPs and work instructions.
• Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), and other relevant documents.
• Assist the Head of DSPV to plan DSPV budget, develop short-term and long-term goals for the department in accordance with overall Company and Development strategies, facilitate department meetings and prepare agendas/meeting minutes.
• 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.
• Occasional international/domestic travel required.
• Other duties as required from time to time.

QUALIFICATIONS:

• Health Care Professional degree is required (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
• Master's level degree or equivalent in Business Administration, Public Health, Epidemiology, Informatics, or related field preferred.
• An Executive Director will have 15+ years' experience in PV Operations at global pharmaceutical or biotechnology companies, including 8+ years' experience as a people manager in PV operations in the clinical trial and post-marketing environments, is required.
• A Senior Director will have 12+ years' experience in PV Operations at global pharmaceutical or biotechnology companies, including 8+ years' experience as a people manager in PV operations in the clinical trial and post-marketing environments, is required. 5+ years' experience as a Department Head of PVO is preferred.
• Proven track record of delivering safety informatics approaches, skills, and tools for drug safety projects.
• Extensive experience in ICSR management/processing, aggregate safety reports, Argus/ArisG Safety Database and MedDRA coding.
• Robust knowledge of local US FDA (CFR Part 11) and Health Canada regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes.
• Broad knowledge of global regulations and guidance, GxP/GVP/ICH guidelines, and other local/global safety regulations.
• Excellent negotiation skills along with strategic thinking and decision-making skills.
• Experienced project manager, projecting confidence and inspiring team to maintain open, transparent communication across the team and with senior leadership towards operational, technical and compliance solutions.
• Proven track record enhancing PV Operations, Systems and Compliance solutions to ensure a steady state of audit and inspection readiness and the highest level of compliance for all requirements.
• Demonstrated agility that enables for innovation, optimization, efficiencies, and proactive collaboration while leading safety operational and system initiatives and realizing pharmacovigilance projects on time and within budget.
• Excellent verbal communication and presentation skills with ability to write clearly and concisely.
• Time management skills with ability to prioritize meeting required deadlines.
• Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment.
• Strong ability to work collaboratively in dynamic small teams of internal and external partners that are a part of a fast-paced environment.

The base salary range for this role is $263,300 to $332,900 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.
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.
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.

Job Tags

Full time, Temporary work, Work at office, Local area, 2 days per week,

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