Medical Director, Safety & Risk Management (SERM)
GSK · Wavre
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
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GSK
Wavre
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