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risk management team leadership clinical operations ich-gcp regulatory compliance
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📋 Description

  • Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies and
  • Translate program strategy into comprehensive, executable operational plans aligned with
  • Accountable for study timelines, budgets, resource allocation, quality metrics, and overall
  • Lead scenario planning, risk forecasting, and mitigation strategies at the program level.
  • Partner with Clinical Development leadership to inform portfolio-level planning and decision-making.
  • Directly manage and develop Clinical Operations staff (e.g., Clinical Study Leads and/or Clinical

🎯 Requirements

  • 12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry.
  • Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) is strongly preferred.
  • Significant experience leading global late-phase (Phase 3) studies.
  • Demonstrated success in direct people management, including hiring, performance management, and
  • Proven ability to lead complex cross-functional teams and influence at senior leadership levels.
  • Strong expertise in CRO oversight, global regulatory environments, and inspection readiness.
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