Oncology Safety & Pharmacovigilance SERM Director

GSK; Waltham (MA); Hybrid; USD 223,000 - 371,000; Full time

Job summary

GSK in the United States is seeking a Medical Safety Lead for oncology assets in clinical development. You will oversee safety evaluation, risk management, and interpretation of safety data to support benefit–risk decisions.

This role requires a medical degree and strong pharmacovigilance experience; you will lead cross‑functional teams, contribute to regulatory submissions, and communicate safety strategies to governance committees. Hybrid US‑based with on‑site governance meetings.

Qualifications

• Medical degree with GMC registration or eligibility to practise in the UK (as per Basic Qualifications)
• 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 medical/regulatory documentation
• Strong clinical judgement and ability to deliver evidence‑based recommendations

Responsibilities

• Lead pharmacovigilance and risk management activities for assigned oncology assets and clinical trials
• Define and drive strategy for 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 data to inform benefit–risk decisions
• Ensure timely escalation of safety concerns in line with governance processes
• Represent Safety on cross-functional Clinical Matrix and Project Teams
• Lead cross-functional teams to address urgent and complex product safety issues
• Lead presentations on safety issues and recommendations to senior governance committees
• Influence decision‑making through clear, credible communication
• Represent GSK in interactions with regulatory authorities and external experts
• Contribute to the development of safety strategy for clinical programmes and broader Safety governance

Skills

Analytical Thinking

Clinical Data Interpretation

Clinical Development

Clinical Pharmacology

Clinical Trial Designs

Clinical Trials Monitoring

Digital Fluency

Drug Regulatory Affairs

Evidence Based Decision Making

Executive Presence

Hematology and Oncology

Learning Agility

Matrix Leadership

Real World Evidence (RWE)

Scientific Presentations

Education

Medical degree

Job description

GSK in the United States is seeking a Medical Safety Lead for oncology assets in clinical development. You will oversee safety evaluation, risk management, and interpretation of safety data to support benefit–risk decisions.

This role requires a medical degree and strong pharmacovigilance experience; you will lead cross‑functional teams, contribute to regulatory submissions, and communicate safety strategies to governance committees. Hybrid US‑based with on‑site governance meetings.