Executive Medical Director, Pharmacovigilance and Drug Safety

We are seeking an Executive Medical Director, Pharmacovigilance and Drug Safety (DSPV), to join our team. The Executive Medical Director, DSPV will play a key leadership role in Drug Safety Pharmacovigilance, building Medical Safety and Risk Management team, supervising and mentoring safety physicians and safety scientists, responsible for safety and benefit-risk assessment 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. The successful candidate 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 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:

• Build and manage Medical Safety Team consisting of safety physicians.
• 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.
• 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:

• Medical degree (MD) required, with at least 2 years’ experience in clinical/medical practice.
• 15+ 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.
• 5+ years’ experience as a people manager.
• 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.

The base salary range for this role is $307,200 to $360,600 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.