SERM Medical Director, Oncology

GSK

Irvine

Hybrid

GBP 110,000 - 160,000

Full time

3 days ago
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Job summary

GSK in the United Kingdom is seeking a Medical leader in pharmacovigilance to provide medical and scientific oversight for safety in oncology assets during clinical development. You will lead signal detection, risk management, and regulatory submissions, working in a hybrid model across international teams; strong communication and cross‑functional collaboration required.

This role offers impact on patient safety and governance, with opportunities to shape global safety strategy.

Qualifications

  • Medical degree with GMC registration (or eligibility to practise in the UK).
  • Postgraduate clinical training required.
  • Significant experience in pharmacovigilance or medical affairs.
  • Demonstrated expertise in signal detection, evaluation, and risk management.
  • Strong understanding of clinical development and post‑marketing safety processes.
  • Experience in cross‑functional, matrixed environments.
  • Excellent written and verbal communication for medical/regulatory documents.

Responsibilities

  • Lead pharmacovigilance and risk management for oncology assets and trials.
  • Define strategy for evaluating and managing safety across development lifecycle.
  • Analyse clinical data and literature to identify safety signals.
  • Provide medical input to regulatory submissions on safety components.
  • Ensure timely escalation of safety concerns per governance processes.
  • Lead Safety Review Teams and collaborate cross-functionally across geographies.

Skills

Pharmacovigilance
Drug safety
Risk management
Signal detection
Regulatory submissions

Education

Medical degree with GMC registration (UK) or eligibility
Postgraduate clinical training (residency or specialty)

Job description

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.

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
  • 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, 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
  • 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 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
Why Join Us?

This is an opportunity to play a pivotal role in advancing GSK’s oncology pipeline, with direct impact 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 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
Working Model

This role is hybrid, based in the United Kingdom, Belgium, Poland, or Italy. 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
Polish Salary Range / Polski przedział wynagrodzenia

PLN 410,250 to PLN 683,750

Italian Salary Range / Fascia retributiva in Italia

EUR 81,750 to EUR 136,250

Belgium Salary Range / Fourchette salariale – Belgique

EUR 119,250 to EUR 198,750

The 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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people surrounding the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also the foundation of a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

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