Clinical Trials Management Director

Sumitomo Pharma Co., Ltd.

Base: $195,500.00 - $244,400.00; bonus/equity: sho...
Fully remote
End-to-end clinical trial lifecycle management
Gcp and ich regulatory compliance expertise
Clinical operations budget forecasting and control
Sumitomo Pharma Co., Ltd. is seeking a Clinical Trials Management Director to lead the planning, execution, and oversight of clinical studies, ensuring compliance with regulatory standards and quality objectives. The role requires extensive experience in clinical operations and a strong understanding of drug development, with a focus on cross-functional collaboration and vendor management

Job Summary

  • The role involves directing the end-to-end planning, execution, and successful completion of clinical studies within oncology and other therapeutic areas.
  • Candidates must ensure adherence to timelines, budgets, and quality standards while maintaining inspection readiness through rigorous Trial Master File management.
  • The position offers a competitive base salary range of $195,500.00 - $244,400.00 along with comprehensive benefits including flexible paid time off and 401(k) eligibility.

Matching Summary

Match Score: 85

Sumitomo Pharma Co., Ltd. is seeking a Clinical Trials Management Director to lead the planning, execution, and oversight of clinical studies, ensuring compliance with regulatory standards and quality objectives. The role requires extensive experience in clinical operations and a strong understanding of drug development, with a focus on cross-functional collaboration and vendor management.

Salary

Base: $195,500.00 - $244,400.00; Bonus/Equity: Short incentive plan participation; Benefits: 401(k), medical, dental, vision, life, disability, flexible PTO, 11 holidays

Skills & Requirements

Must-have

  • End-to-end clinical trial lifecycle management
  • GCP and ICH regulatory compliance expertise
  • Clinical operations budget forecasting and control
  • Vendor and CRO performance management
  • Cross-functional team leadership and collaboration

Nice-to-have

  • Experience with stem cell and regenerative medicine
  • Global patient population study management
  • Strong phase 1/2 therapeutic experience
  • Process improvement and policy development
  • Remote work independence and initiative

Key Requirements

  • Bachelor's or advanced degree in life sciences
  • 10-15 years relevant experience in biotech/pharma/CRO
  • Minimum 8-12 years experience with Master's degree
  • Proven experience supporting Phases 1-4 clinical studies

Work Rights

Not specified

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