SERM Scientific Director

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.

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.

Salary

Belgium Salary Range: EUR to EUR .

Equal Opportunity Employer

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.