Executive Medical Director, SERM Scientific Excellence

Overview

The Executive Medical Director, Safety Evaluation and Risk Management (SERM) Scientific Excellence is an integral figure within GSK's Global Safety team, reporting to the Vice President and Head of Vaccines and Infectious Disease Safety. This senior-level role focuses on advancing scientific safety standards and practices, predominantly within Vaccines SERM, but also across other therapeutic areas when needed. You will play role in shaping safety approaches for early-phase and non-pivotal trials, as well as studies involving vulnerable populations.

As the study-independent chair of the internal Safety Review Committee (iSRC), you will also ensures the scientifically sound review and interpretation of unblinded safety data, protecting trial participants while maintaining the integrity of clinical trials. This multifaceted position provides an opportunity to be a pivotal driver in enhancing patient safety during early clinical development phases, setting global standards for safety governance, and cultivating a high-performing culture within GSK.

Successful candidates will bring deep expertise in clinical practice, drug safety / pharmacovigilance, and scientific data analysis, combined with leadership capabilities to build cross-functional relationships and drive forward GSK's mission of delivering innovative healthcare solutions to patients worldwide.

• Lead the definition, maintenance, and implementation of standardised and compliant safety approaches for first-in-human, early-phase trials, and studies involving vulnerable populations, while adapting strategies to align with evolving regulatory expectations.
• 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.

• 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.

• Proven track record of identifying and addressing capability gaps within teams through the design and execution of formal development programs.
• 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.
• Creative problem-solving expertise and sound judgment in critical safety situations while maintaining a strategic and tactical view of organisational goals.

This role can be based in the United Kingdom, Belgium or Italy. Hybrid working is supported, with regular on-site collaboration expected to build effective teamwork and stakeholder relationships.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

We're uniting science, technology, and talent to get ahead of disease together.

GSK is an Equal Opportunity Employer. This ensures that all…