Responsibilities
- Design and implement clinical strategies across all development phases using internal and external resources
- Lead Clinical Operations team and oversee compliance with FDA, EU, and ICH guidelines and SOPs
- Manage clinical study budgets, timelines, and performance metrics to meet corporate objectives
- Manage CRO relationships and external vendor expectations as primary liaison
- Recruit, train, and support career development of direct reports within clinical operations
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
- Knowledge of ICH, GCP, FDA regulations, and EU directive
- Experience directing global studies in endocrine indications or rare diseases
- Strategic vendor management expertise, particularly with CROs
- Leadership ability to manage, mentor, and develop multiple direct reports
- Cross-functional collaboration skills in matrix organization environments
Vacancy posted 27 days ago
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