Oncology Safety & Risk Director

GSK; United Kingdom; On-site; GBP 100,000 - 170,000; Full time

Job summary

GSK is seeking a Scientific Director of Safety Evaluation & Risk Management in oncology to lead pharmacovigilance activities, drive risk mitigation, and shape safety strategy across clinical development programs.

The role engages cross-functional teams, mentors colleagues, and interfaces with regulatory authorities to ensure robust benefit-risk profiles and timely safety decisions across global assets.

Qualifications

• Degree in a health or life sciences discipline.
• Extensive experience in pharmacovigilance, drug safety, or related safety evaluation role in the pharmaceutical or biotech industry.
• Practical experience in signal detection, safety surveillance and risk management across clinical development and post-marketing.
• Knowledge of global pharmacovigilance requirements and drug development processes.
• Strong clinical or scientific judgement with experience interpreting clinical and safety data.

Responsibilities

• 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 programs.
• 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 of outputs while managing multiple priorities.
• 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 and present at Safety Review Team (SRT) meetings.
• Escalate emerging safety issues to senior leadership and governance bodies as appropriate.
• Build strong working relationships and effectively lead within a global matrix environment.
• Mentor and coach junior team members as applicable.
• Present safety recommendations and emerging risks to senior governance committees with clarity and impact.
• 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 long-term safety and clinical development strategies.
• Drive continuous improvement by introducing innovative approaches to safety evaluation and processes.
• Communicate complex scientific information effectively to diverse audiences.

Skills

Digital Fluency

Enterprise Leadership

Influencing Without Authority

Pharmacovigilance

Presentation Techniques

Education

Bachelor's degree in health or life sciences

Job description

GSK is seeking a Scientific Director of Safety Evaluation & Risk Management in oncology to lead pharmacovigilance activities, drive risk mitigation, and shape safety strategy across clinical development programs.

The role engages cross-functional teams, mentors colleagues, and interfaces with regulatory authorities to ensure robust benefit-risk profiles and timely safety decisions across global assets.