Global Medical Affairs Director at ViiV Healthcare ensuring effective communication of HIV prevention research. Leading training and data compliance efforts for clinical specialists and outside health care providers.
About the role
- 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
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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