Senior Director of Clinical Operations

Job Summary

Providing leadership for strategic projects, the full-time Senior Director of Clinical Operations will oversee clinical operations and study management activities, manage vendor relationships, and ensure compliance with regulatory standards in a remote environment.

Key responsibilities

• Leads clinical operations and study management activities, including vendor selection and oversight of Phase 1 clinical studies
• Collaborates with sponsors and stakeholders to develop business requirements and ensure compliance with SOPs and regulatory guidelines
• Provides training and expert input into clinical study documents while managing vendor agreements and budgets

Required qualifications

• Bachelor's degree required; science-based education preferred, with a minimum of fifteen years of related experience in the CRO, pharmaceutical, or biotechnology industry
• At least 5 years of experience in early development and Phase I clinical operations
• Expertise in Phase 1 drug development, operations, and strategic planning
• Knowledge of clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance
• Experience managing CROs, clinical vendors, and contracts, along with proficiency in MS Office and project planning tools