Executive Medical Director responsible for safety evaluation and risk management for vaccines at GSK. Leading clinical safety standards and practices in early-phase and non-pivotal trials.
Responsibilities
Lead the definition, maintenance, and implementation of standardised and compliant safety approaches for first-in-human, early-phase trials, and studies involving vulnerable populations
Serve as the study-independent chair of the internal Safety Review Committee (iSRC), driving scientifically robust reviews and guiding the interpretation of unblinded safety data to ensure participant protection and safeguard trial integrity
Collaborate with study teams to establish appropriate safety endpoints, monitoring and surveillance methods, risk mitigation strategies, and plans for the timely analysis of emerging safety signals
Guide decision-making processes in critical review bodies such as Data Monitoring Committees and Dose Escalation Committees to ensure the proper escalation and response to safety concerns
Oversee the readiness and optimisation of systems for safety data collection, reporting, and analysis throughout clinical trial preparation and execution, enabling proactive signal detection and mitigation
Provide leadership in developing scientific capabilities within SERM teams by coaching physicians and scientists, introducing innovative analytical approaches, and fostering continuous learning and improvement
Serve as a culture champion for high performance within Global Safety while actively contributing to strategies for the evaluation and management of urgent product safety issues
Requirements
Medical Doctor
Completion of a primary postgraduate clinical training, clinical residency or specialty training
Extensive, hands-on safety and pharmacovigilance knowledge and expertise in scientific safety data analysis, interpretation, and evaluation
Proficiency in applying frameworks for reviewing unblinded safety data with meticulous attention to study integrity
Solid understanding in vaccinology, epidemiology, and biostatistics as applied to clinical safety analysis
Exceptional communication skills, enabling clear and impactful presentation of complex scientific data to internal and external audiences alike
Leadership experience in developing talent, fostering collaboration, driving change management, and cultivating a high-performing operational culture, especially in cross-functional, global environments.
Benefits
Opportunities to grow your career
Lead high-value projects
Work with committed colleagues who share a clear purpose
Encourage an inclusive culture
Job title
Executive Medical Director, SERM Scientific Excellence
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