SERM Medical Director

Overview

As Medical Safety Lead for immunology assets, you will guide pharmacovigilance and risk management across trials and the development lifecycle. You provide expert safety interpretation to support benefit–risk decisions and contribute to global governance. You will lead cross-functional teams, communicate safety implications to governance bodies, and shape safety strategies for clinical programmes in a global, matrix environment.

Pay / Benefits

• annual bonus
• share-based long-term incentive program
• hybrid working model (UK/Poland)
• remote/hybrid balance
• competitive salary (Polish ranges disclosed)
• adjustments available during application/interview

Responsibilities

• Lead pharmacovigilance and risk management activities for immunology assets and trials
• Define and drive safety strategy across the clinical development lifecycle
• Analyze clinical data and literature to identify and assess safety signals
• Contribute medical input to safety components of regulatory submissions
• Escalate safety concerns timely in line with governance
• Represent Safety on cross-functional Clinical Matrix and Project Teams
• Lead or participate in Safety Review Teams (SRTs)
• Foster cross-functional collaboration and capability development
• Communicate safety issues and recommendations to senior governance committees
• Shape overall safety strategy and engage with regulators and external experts

Key requirements

• Medical degree and clinical experience
• Residency or specialty training completed or eligible (UK)
• Significant pharmacovigilance/drug safety experience
• Expertise in signal detection, evaluation, and risk management
• Strong understanding of clinical development and post-marketing safety processes
• Experience working in matrixed, cross-functional environments
• Excellent written and verbal communication for medical/regulatory documents
• Strong clinical judgement and evidence-based decision-making
• GMC registration (preferred)
• Experience with safety submissions and regulatory interactions (preferred)

• Excellent communication
• Influence and executive presence
• Collaboration in global matrix environment
• Pharmacovigilance and drug safety
• Signal detection and risk management
• Clinical development knowledge

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