Clinical Operations Director

3 weeks ago


Waltham, Massachusetts, United States Upstream Bio Full time
Join Our Team as a Clinical Operations Director

We are seeking a highly skilled and experienced Clinical Operations Director to lead our clinical trials and contribute to our clinical development plan strategy across our indications. As a key member of our team, you will plan, oversee, and drive the delivery of clinical studies in a fully outsourced model.

Key Responsibilities:
  • Develop and implement clinical operational strategies for successful delivery of assigned clinical studies.
  • Partner with Clinical Research Organizations (CROs) to ensure effective risk identification and mitigation strategies.
  • Oversee high-quality implementation, execution, and delivery of studies by CROs in alignment with timeline and budget plans.
  • Establish an open team culture defined by transparent communication, clear goal setting, and risk-based oversight.
  • Ensure compliance with internal policies and procedures, Good Clinical Practice (GCP), and applicable regulations.
Qualifications:
  • Bachelor's Degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.
  • 10+ years of relevant clinical development and operations experience, in clinical operations leadership roles, leading global clinical studies/programs.
  • Experience overseeing respiratory clinical trials preferred.
Skills, Knowledge & Abilities:
  • Strong leadership skills driving large cross-functional teams.
  • Deep knowledge of global regulatory and compliance requirements for clinical research, local country requirements, and ICH GCP.
  • Excellent critical and strategic thinking, with strong ability to understand the big picture as well as the important details that may impact the big picture.


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