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 and forecast management
The role involves directing the end-to-end planning, execution, and successful completion of clinical studies within oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS programs

Job Summary

  • The role involves directing the end-to-end planning, execution, and successful completion of clinical studies within oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS programs.
  • 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 a 401(k) plan.

Matching Summary

The role involves directing the end-to-end planning, execution, and successful completion of clinical studies within oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS programs.

Salary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Experience with global patient population studies
  • Therapeutic background in stem cells and regenerative medicine
  • Strong phase 1/2 clinical trial experience
  • Process improvement and policy development skills
  • Ability to work in a fast-paced remote environment

Key Requirements

  • Bachelor's or advanced degree in life sciences or related field
  • 10-15 years of relevant experience in biotech/pharma/CRO setting
  • Minimum 8-12 years experience if holding a Master's degree
  • Proven experience supporting Phases 1-4 clinical studies

Work Rights

Not specified

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