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Director, Clinical Operations

$190.5k - $260k

Neurocrine Biosciences

Responsibilities

  • Develop and execute clinical operation strategies across all phases of drug development programs
  • Lead clinical operations team including Associate Directors, Trial Managers, and Specialists
  • Ensure regulatory compliance with FDA, EU directives, and ICH guidelines across all studies
  • Establish budgets, timelines, and performance metrics for clinical programs and individual studies
  • Manage CRO relationships, vendor contracts, and cross-departmental coordination with Regulatory and QA

Requirements

  • Bachelor's degree in scientific field plus 12+ years clinical research experience in pharma/biotech/CRO
  • Master's degree in scientific field or MBA plus 10+ years similar clinical research experience
  • Deep knowledge of ICH, GCP, FDA regulations, and EU directives
  • Demonstrated experience directing global clinical studies in endocrine indications or rare diseases
  • Strategic vendor management expertise, particularly with CROs
  • Proven ability to lead, mentor, and motivate clinical operations teams
  • Strong cross-functional collaboration and matrix environment navigation skills
Vacancy posted 22 days ago
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