Senior Medical Director, Pharmacovigilance and Drug SafetyBoston, MA, USA Req #298
Thursday, August 1, 2024
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.
About the Role:
We are seeking a Senior Medical Director, Pharmacovigilance and Drug Safety (DSPV) to join our team. The Senior Medical Director, DSPV will play a key leadership role in Drug Safety Pharmacovigilance, building the Medical Safety and Risk Management team, responsible for safety and benefit-risk assessment of assigned Xenon products throughout the product lifecycle (from First-In-Human to post-marketing). This role includes 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 position reports to the Executive Director, Pharmacovigilance and Drug Safety and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates.
RESPONSIBILITIES: Responsible for signal management, risk management, and benefit-risk assessment of all Xenon's products throughout the product lifecycle from First-In-Human to post-marketing.Provide strategic leadership in safety surveillance for Xenon's clinical development programs and lead the safety perspective in NDA submissions.Review safety data of non-clinical studies to inform clinical development strategies and plans, including dose escalation protocols.Lead cross-functional Safety Management Teams (SMT) to review safety data from all sources to detect, evaluate, monitor, and minimize safety signals/risks.Lead SMT to address any safety-related issues for Xenon products throughout product lifecycle from First-in-Human (FIH) to post-marketing.Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment.Review potential safety signals and contribute to the Safety Governance process through the preparation and presentation of safety data.Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), and Clinical Study Reports (CSR).Perform medical review of ICSRs in Xenon's Global Safety Database.Develop Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR) and responses to health authorities' requests for safety information.Assist the Head of DSPV to prepare and maintain safety related SOPs/WIs in compliance with the global safety regulations and guidelines.Collaborate with Clinical Development and Medical Affairs to develop publications and clinical data communications.Lead the negotiation of drug safety and risk management related activities in pharmacovigilance agreements.Act in accordance with Company policies, including the Code of Business Conduct and Ethics.Other duties as assigned.QUALIFICATIONS: Medical degree (MD) required, with at least 2 years' experience in clinical/medical practice.12+ years' experience in global pharmaceutical or biotechnology companies, including 10+ years' experience as a safety physician leading SMT in drug safety & pharmacovigilance.Experience in authoring safety signal assessment reports and safety regulations.Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines.Experience with Argus Safety Database and MedDRA coding.Excellent verbal communication and presentation skills.Time management skills with ability to prioritize meeting required deadlines.Strong ability to work collaboratively in dynamic small teams.The base salary range for this role is $307,200 to $327,900 USD; we will consider above this range for exceptional candidates. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits.
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.
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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