SERM Scientific Director

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 advanced scientific expertise in the safety evaluation and risk management of key GSK oncology assets in clinical development. Leads the identification, assessment, and communication of safety risks to ensure robust benefit-risk profiles and protection of patients globally. This role plays a critical part in shaping the safety strategy of innovative oncology therapies, partnering cross-functionally to enable high-quality, timely decision-making and proactive risk mitigation across the portfolio.

Key Responsibilities

Scientific and Pharmacovigilance Leadership

• Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials
• Drive the evaluation and interpretation of safety data, including signal detection and assessment
• Develop strategic approaches for safety issue evaluation within clinical development programmes
• Contribute to safety components of global regulatory submissions (e.g., INDs, DSURs, IBs)
• Perform literature review, clinical data synthesis, and integrated safety analyses to inform decision-making
• Ensure high-quality, timely delivery while managing multiple priorities

Cross-Functional Matrix Leadership

• Represent Safety Evaluation & Risk Management (SERM) on Clinical Matrix and Project Teams
• Lead cross-functional efforts to address urgent and complex product safety issues
• Partner closely with Safety Physicians and stakeholders to prepare for and contribute to Safety Review Team (SRT) meetings
• Escalate emerging safety issues to senior leadership and governance bodies as appropriate
• Build strong working relationships and lead effectively within a global matrix organisation
• Coach and mentor colleagues as appropriate

Communication, Influence and Strategy

• Present safety recommendations and emerging risks to senior governance committees
• Represent GSK in interactions with regulatory authorities, external experts, and partners
• Apply strategic thinking to evaluate internal and external factors influencing safety decisions
• Contribute to the development of long-term safety and clinical programme strategies
• Identify opportunities for continuous improvement and innovation in safety evaluation processes
• Communicate complex scientific information clearly to a range of audiences

Basic Qualification

• Degree in a health-related discipline (e.g., Life Sciences, Pharmacy, Medicine, Nursing), with significant relevant experience
• Substantial experience in pharmacovigilance, drug safety, or a related function within the pharmaceutical or biotechnology industry
• Experience supporting safety in oncology clinical development programmes
• Strong expertise in:
  • Signal detection and risk assessment
  • Clinical trial safety oversight
  • Regulatory safety documentation and submissions
• Knowledge of global pharmacovigilance regulations (e.g., ICH, GVP, CIOMS)
• Proven ability to work effectively in a complex, global matrix environment
• Strong analytical, communication, and problem-solving skills

Preferred Qualification

• Advanced degree (e.g., PhD, PharmD, MD or equivalent)
• Experience interacting with global regulatory authorities
• Experience presenting to senior governance or safety review committees
• Demonstrated leadership experience, including mentoring or team leadership in a matrix setting
• Track record of influencing cross-functional teams and contributing to strategic decision-making
• Experience supporting late-stage clinical development programmes

Working arrangement

This is a hybrid role based in the United Kingdom with a mix of office and remote working. Some travel may be required for meetings and regulatory interactions.

What we value

We seek people who work with integrity, focus on patients and collaborate respectfully. We welcome different perspectives and promote inclusion in our teams. We support development and learning so you can grow while making a meaningful impact on patient safety.

Belgium Salary Range / Fourchette salariale – Belgique:

EUR 111,750 to EUR 186,250. 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.

Why GSK?

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.