Executive Medical Director/SERM Head - Oncology

Role Summary

Executive Medical Director / SERM Head - Oncology is a leadership role within the Global Safety Evaluation and Risk Management team. This position shapes and drives the clinical safety and pharmacovigilance strategy across the Oncology portfolio to ensure patient safety and regulatory compliance.

Responsibilities

• Lead and inspire a global team of senior medical and scientific safety professionals.
• Define and drive the strategic direction and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategy.
• Oversee benefit-risk management activities across the assigned portfolio throughout the lifecycle, to ensure patient safety globally. Anticipate, detect and address product safety issues and ensure that risk-reduction strategies are implemented appropriately.
• Ensure scientific rigor in safety data evaluation, interpretation, and communication. Make recommendations for the further characterization, management, and communication of safety risks.
• Represent Global Safety with confidence, impact, integrity and professionalism both internally, in cross-functional governance, and with key external stakeholders including regulators and industry forums.
• Drive continuous improvement and compliance with applicable processes and standards and maintain readiness in internal audit or regulatory inspection.
• Lead or oversee SERM contribution to due diligence activities.
• Lead enterprise-wide activities such as safety advisory panels, interfaces with and assumes ad hoc membership of a Senior Governance Committee.

Qualifications

• Required: Medical degree and a clinical medical specialty qualification
• Required: Extensive experience in clinical safety, pharmacovigilance, or drug development within the pharmaceutical or biotech industry.
• Required: Demonstrated expertise in Oncology and/or Hematology therapeutic areas.
• Required: Proven leadership in global safety strategy and team management.
• Preferred: Deep understanding of regulatory requirements and benefit-risk methodologies.
• Preferred: Exceptional communication and stakeholder engagement skills.
• Preferred: Experience working in matrixed, global environments.
• Preferred: Familiarity with both clinical development and post-marketing safety.