Oncology Medical Director — Safety & Risk Leadership

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

Benefits offered by this job

Health benefits

Retirement plan

Paid holidays

Vacation policy

Family leave

Job summary

GSK in the United States (hybrid base in Cambridge, MA; Waltham, MA area) seeks a medical safety leader to guide pharmacovigilance and risk management for oncology assets. You will shape strategy, interpret data, and influence global regulatory submissions while coordinating across matrixed teams and geographies.

The role demands medical degree with relevant clinical experience, strong communication, and proven ability to drive safety decisions in complex datasets and governance processes.

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

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
• Analyseand interpret clinical data, literature, and emerging evidence toidentifyand 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
• Ensuretimelyescalation 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
• Actively contribute to and, whereappropriate, lead Safety Review Teams (SRTs)
• Build strong, collaborative relationships across functions and geographies
• Coach and mentor colleagues, contributing to capability development within theorganisation
• Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders
• 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 programmesand broader SERM activities
• Identifyopportunities to improve processes, drive innovation, and enhance operational effectiveness
• Operate with strong awareness of the internal and external regulatory and scientific environment

Job description

GSK in the United States (hybrid base in Cambridge, MA; Waltham, MA area) seeks a medical safety leader to guide pharmacovigilance and risk management for oncology assets. You will shape strategy, interpret data, and influence global regulatory submissions while coordinating across matrixed teams and geographies.

The role demands medical degree with relevant clinical experience, strong communication, and proven ability to drive safety decisions in complex datasets and governance processes.