SERM Medical Director

GSK; Sint-Katelijne-Waver; Sur place; EUR 119 000 - 199 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

GSK is seeking a medical leader to drive safety evaluation and risk management for its oncology assets in clinical development. You will interpret complex data, identify safety signals, and influence benefit–risk decisions across regulatory submissions and governance structures.

The role requires GMC registration eligibility, postgraduate training, and extensive pharmacovigilance experience. The position is hybrid, with on-site governance activities in the UK and international collaboration.

Qualifications

• Medical degree with GMC registration or eligibility to practise in the UK.
• Postgraduate clinical training completed (e.g., residency or specialty training).
• Significant pharmacovigilance, drug safety, or medical affairs experience.
• Demonstrated expertise in signal detection, evaluation and risk management.
• Strong understanding of clinical development and post‑marketing safety processes.

Responsabilités

• Lead pharmacovigilance and risk management for oncology assets and trials.
• Define strategy for safety issue evaluation across the development lifecycle.
• Interpret clinical data, literature and emerging evidence to assess safety signals.
• Provide medical input into safety components of regulatory submissions.
• Escalate safety concerns timely per governance processes.
• Lead cross-functional teams to address safety issues and participate in SRTs.

Connaissances

Clinical Development

Communication

Regulatory Affairs

Evidence Based Decision Making

GCP

Influencing

Learning Agility

People Management

Project Management

Medical Presentations

Strategic Thinking

Formation

Medical degree

Postgraduate training

Pharmacovigilance experience

Regulatory submissions experience

Description du poste

Business Introduction
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.

Find out more:
Our approach to R&D

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

Scientific / Medical & Pharmacovigilance Expertise

• 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

• Analyseand interpret clinical data, literature, and emerging evidence toidentifyand 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

• Ensuretimelyescalation of safety concerns in line with governance processes

Matrix Leadership & Cross-functional Collaboration

• 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, whereappropriate, lead Safety Review Teams (SRTs)

• Build strong, collaborative relationships across functions and geographies

• Coach and mentor colleagues, contributing to capability development within theorganisation

• Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders

Communication, Influence & Governance

• 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 clinicalprogrammesand broader SERM activities

• Identifyopportunities to improve processes, drive innovation, and enhance operational effectiveness

• Operate with strong awareness of the internal and external regulatory and scientific environment

Why Join Us?

This is an opportunity to play a pivotal role in advancing GSK’s oncology pipeline, withdirectimpact on patient safety and global health outcomes.

You will:

• Shape the safety strategy of innovative oncology medicines

• Engage with senior governance and influence key development decisions

• Work within a highly collaborative, global matrix environment

• Contribute to scientific excellence and continuous improvement in safety science

Basic Qualifications

• Medical degree with current GMC registration (or eligibility topractisein the UK) and relevant clinical experience

• Completion of formal postgraduate clinical training (e.g., residency or specialty training)

• Significant experiencein pharmacovigilance, drug safety, or medical affairs

• Demonstratedexpertisein 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

• Postgraduatespecialisationin 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 majorprogrammes

• Prior engagement with regulatory authorities and external safety forums

• Demonstrated ability to coach and develop colleagues in medical, scientific, or safety roles

Working Model
This role is hybrid, based in the United Kingdom. You will be expected on site for key meetings, governance activities and team collaboration. Remote working is supported to balance focused work and stakeholder engagement.

Skills

Clinical Development, Communication, Drug Regulatory Affairs, Evidence Based Decision Making, Good Clinical Practice (GCP), Influencing Without Authority, Learning Agility, People Management, Project Management, Scientific Presentations, Strategic Thinking

Belgium Salary Range / Fourchette salariale – Belgique: EUR 119,250 to EUR 198,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.