Senior Medical Director, Pharmacovigilance & Drug Safety

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 XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our XEN1101 Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures. In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 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 Medical Director, Pharmacovigilance and Drug Safetyto join our team. The incumbent will play a key leadership role in Drug Safety Pharmacovigilance, building 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), 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 lead the safety perspective of NDA submissions, lead cross-functional Safety Management Teams, and collaborate with colleagues in Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics and Programming, Data Management, Regulatory Affair, Medical Affair, non-clinical safety lead, QA and Legal departments.
This position reports to the Senior Vice President, Pharmacovigilance and Drug Safety and will be located in the Boston, MA, USA location.
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; to provide strategies for risk management/mitigation and develop dRMP/RMP/REMS; to evaluate the Benefit-Risk profiles of Xenon products.
• Lead SMT to address any safety-related issues for Xenon products throughout product lifecycle from First-in-Human (FIH) to post-marketing, including safety monitoring in clinical trials, safety assessment for potential signals/risks, responses to Health Authority requests, strategic guidance during NDA submissions, and creating and maintaining RSI in IB and CSI in CDS for Xenon products.
• 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; prepare and assess safety data for ongoing periodic / aggregate safety data reviews and provide recommendations for review and approval by the Safety Advisory Committee.
• Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, Manuscripts, and other relevant documents.
• Perform medical review of ICSRs in Xenon's Global Safety Database including but not limited to case narrative, MedDRA coding, labeling, causality, company comment and queries.
• Develop 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.
• Assist the Head of DSPV to prepare and maintain safety related SOPs/WIs in compliance with the global safety regulations and guidelines, provide training and mentoring, lead corporate initiatives and inspection/launch readiness, 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.
• Collaborate with Clinical Development and Medical Affairs to develop publications and clinical data communications; review scientific publications such as posters, abstracts, and manuscripts.
• Lead the negotiation of Drug Safety and risk management related activities in pharmacovigilance agreements with license partners and distributors.
• 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:

• Medical degree (MD) required, with at least 2 years' experience in clinical/medical practice.
• 12+ years' experience in at global pharmaceutical or biotechnology companies, including 10+ years' experience as a safety physician leading SMT in Drug Safety & pharmacovigilance for products in clinical trial and post-marketing environments.
• Experience in authoring safety signal assessment report, DSUR, PBRER, RMP/REMS, and RSI.
• Experience in drug development process, clinical development and NDA submissions.
• Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations.
• Experience with Argus Safety Database and MedDRA coding.
• 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.

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.
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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