Oncology Safety Lead & Medical Director

GSK plc

Oaks (PA)

Hybrid

USD 223,000 - 371,000

Full time

4 days ago
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Benefits offered by this job

Health care benefits
Retirement benefits
Paid holidays

Job summary

GSK is seeking a safety-focused medical leader to guide pharmacovigilance and risk management for oncology assets in clinical development. The role involves interpreting safety data, escalating signals, and delivering evidence-based safety recommendations for global governance.

You will shape safety strategies, collaborate with regulatory authorities, and influence key development decisions within a hybrid US-based setting. Strong leadership and communication are essential.

Qualifications

  • Medical degree with 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 evaluation and management of safety issues across the development lifecycle.
  • Analyse and interpret clinical data, literature, and emerging evidence to identify and assess safety signals.
  • Provide expert medical input into safety components of regulatory submissions.
  • Escalate safety concerns promptly per governance processes.
  • Represent Safety on cross-functional Clinical Matrix and Project Teams.
  • Lead cross-functional teams to address urgent and complex product safety issues.
  • Mentor colleagues and contribute to capability development.
  • Communicate with Safety Leads, senior SERM leadership, and stakeholders.
  • Identify opportunities to improve processes, drive innovation, and enhance operations.

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
Scientific Presentations

Education

Medical degree (MD) with GMC registration or eligibility

Job description

GSK is seeking a safety-focused medical leader to guide pharmacovigilance and risk management for oncology assets in clinical development. The role involves interpreting safety data, escalating signals, and delivering evidence-based safety recommendations for global governance.

You will shape safety strategies, collaborate with regulatory authorities, and influence key development decisions within a hybrid US-based setting. Strong leadership and communication are essential.

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