SERM Medical Director, Oncology

Position Summary

Provides medical and scientific leadership in the safety evaluation and risk management of GSK’s oncology assets in clinical development. Responsible for the interpretation of safety data, identification and escalation of safety signals, and delivery of clear, evidence-based recommendations to support benefit–risk decisions. This role contributes to global governance and plays a critical part in protecting patient safety and shaping the safety profile of innovative oncology medicines.

Key Responsibilities

• Lead pharmacovigilance and risk management activities for assigned oncology assets and clinical trials
• Define and drive strategy for the evaluation and management of safety issues across the clinical development lifecycle
• Analyse and interpret clinical data, literature, and emerging evidence to identify and assess safety signals
• Provide expert medical input into the safety components of global regulatory submissions
• Apply sound clinical judgement to complex and sometimes conflicting data sets to inform benefit–risk decisions
• Ensure timely escalation of safety concerns in line with governance processes
• Represent Safety on cross-functional Clinical Matrix and Project Teams
• Lead cross-functional teams to address urgent and complex product safety issues
• Actively contribute to and, where appropriate, lead Safety Review Teams (SRTs)
• Build strong, collaborative relationships across functions and geographies
• Coach and mentor colleagues, contributing to capability development within the organisation
• Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders
• Lead presentations on safety issues and recommendations to senior governance committees
• Influence decision-making through clear, credible, and evidence-based communication
• Represent GSK in interactions with regulatory authorities, external experts, and partners
• Contribute to the development of safety strategy for clinical programmes and broader SERM activities
• Identify opportunities to improve processes, drive innovation, and enhance operational effectiveness
• Operate with strong awareness of the internal and external regulatory and scientific environment

Basic Qualifications

• Medical degree with current GMC registration (or eligibility to practise in the UK) and relevant clinical experience
• Completion of formal postgraduate clinical training (e.g., residency or specialty training)
• Significant experience in pharmacovigilance, drug safety, or medical affairs
• Demonstrated expertise in signal detection, evaluation, and risk management
• Strong understanding of clinical development and post-marketing safety processes
• Experience working effectively in matrixed, cross-functional environments
• Excellent written and verbal communication skills, including preparation of medical and regulatory documents
• Strong clinical judgement and the ability to deliver clear, evidence-based recommendations

Preferred Qualifications

• Postgraduate specialisation in a clinical discipline or pharmaceutical medicine
• Experience contributing to regulatory submissions and periodic safety reports
• Knowledge of epidemiology, biostatistics, or real-world evidence relevant to safety assessment
• Experience leading Safety Review Teams or acting as safety lead for major programmes
• Prior engagement with regulatory authorities and external safety forums
• Demonstrated ability to coach and develop colleagues in medical, scientific, or safety roles