Vir Biotechnology is seeking an experienced Senior Director to be the Head of our Medical Safety function. Within Vir’s Global Pharmacovigilance & Risk Management (PVRM) department, you will provide medical expertise and strategic direction while overseeing the medical safety team, including responsibility for signal management, risk management, and monitoring the safety profile of Vir products. You will shape the strategy and implement pharmacovigilance and risk management activities throughout the product lifecycle (from First-In-Human through post-marketing), assessing benefit-risk profiles, and ensuring corporate compliance with all applicable US and foreign legal and regulatory requirements for signal detection, evaluation, and risk management of Vir products. You will seek to optimize and implement approaches to support the scientific evaluation of the safety risk profile of Vir products.  You will collaborate cross-functionally with colleagues in Clinical Research & Development, Clinical Operations, Clinical Pharmacology, Biometrics, Regulatory Affairs, Medical Affairs, non-clinical safety, QA, and Legal teams.

This Senior Director, Global PVRM Medical Safety will perform as a hands-on team leader who is collaborative, a self-starter, and able to work in a matrixed environment. You will report to the Vice President, Global Pharmacovigilance & Risk Management.

This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.

WHAT YOU'LL DO

• Develop talent and provide leadership to Global PVRM Medical Safety team
• Provide strategic planning, implementation, and management of Global PVRM Medical Safety activities
• Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing global regulations
• Support inspection readiness and provide expertise in audits, inspections, and CAPAs
• Responsible for development of Global PVRM Medical Safety related procedural documents
• Represent Global PVRM Medical Safety as a leader on project teams and committees
• Lead Safety Review Management Team to address any safety-related issues for Vir products, including safety monitoring in clinical trials, safety assessment for potential signals/risks, responses to Health Authority requests, strategic guidance during NDA/BLA submissions, and creating and maintaining core safety information in Investigator Brochures, Company Core Data Sheets, and local labels for Vir products
• Contribute to safety related sections of clinical study documents (e.g., Study Protocols, Informed Consent Forms, Statistical Analysis Plans, Clinical Study Reports, IB Reference Safety Information, Summary of Clinical Safety, Integrated Clinical Safety, Publications, Manuscripts)
• Perform medical review of Individual Case Safety Reports
• Perform medical review and analysis for aggregate safety reports and responses to ad-hoc requests for safety information
• Provide leadership in regulatory authority interactions regarding safety and risk management
• Lead the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activities

WHO YOU ARE AND WHAT YOU BRING

• Medical degree (MD/DO)or equivalent required, with at least 2 years of experience in clinical/medical practice8+ years of experience in pharmacovigilance leadership roles
• Experience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI
• Experience with signal detection process and managing safety information from clinical development and post-marketing sources
• Experience with Global regulations and ICH guidance governing pharmacovigilance and risk management
• Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding
• Must have demonstrable experience in people management at a leadership level and well-developed skills in team building, motivating, empowering, and developing talent