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Medical Director, Safety & Risk Management (SERM)

GSK · Wavre

Senior 🇬🇧 English

Job description

About the role

GSK is seeking a senior Medical Director to lead Safety & Risk Management (SERM) for its oncology portfolio. The role provides medical and scientific leadership in evaluating safety data, managing risk, and supporting benefit‑risk decisions throughout clinical development.

Key responsibilities

  • Lead pharmacovigilance and risk‑management activities for assigned oncology assets and clinical trials.
  • Define and execute safety evaluation strategies across the clinical development lifecycle.
  • Analyse clinical data, literature and emerging evidence to identify safety signals and provide evidence‑based recommendations.
  • Prepare medical input for global regulatory submissions and ensure timely escalation of safety concerns.
  • Represent Safety on cross‑functional Clinical Matrix and Project Teams, leading Safety Review Teams when required.
  • Present safety issues to senior governance committees and interact with regulatory authorities and external experts.
  • Mentor and coach colleagues, driving capability development and process improvement.

Required profile

  • Medical degree (MD or equivalent) with extensive experience in pharmacovigilance and oncology drug development.
  • Proven track record of leading safety evaluation and risk‑management activities in a global pharmaceutical environment.
  • Strong clinical judgement and ability to interpret complex data sets.
  • Excellent communication skills for influencing senior stakeholders and regulatory bodies.

Required skills

  • Pharmacovigilance and risk‑management expertise.
  • Oncology clinical development knowledge.
  • Regulatory submission experience.
  • Cross‑functional leadership and matrix management.

What we offer

  • Opportunity to shape the safety profile of innovative oncology medicines.
  • Collaborative global environment with leading scientists and clinicians.
  • Competitive compensation and benefits package.

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Published 1 month ago

Expires 4 weeks from now

28 views · 0 interested

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GSK

Wavre