Clinical Operations Director

Job Summary

Providing leadership for strategic projects, the full-time salaried Clinical Operations Director will oversee clinical operations and study management activities, manage vendor relationships, and ensure compliance with regulatory standards while collaborating with cross-functional teams.

Key responsibilities

• Leads clinical operations and study management, including vendor selection and oversight of Phase 1 clinical study conduct
• Collaborates with sponsors and stakeholders to develop business requirements and communicate project progress
• Participates in the writing of key clinical study documents and ensures compliance with SOPs, ICH/GCP guidelines, and local laws

Required qualifications

• Bachelor's degree required; science-based education preferred
• Minimum of fifteen years of experience in the CRO, pharmaceutical, or biotechnology industry, with at least 5 years in early development, Phase I experience
• Experience managing direct reports and leading multi-disciplinary teams
• Knowledge of clinical pharmaceutical standards and regulatory compliance in the USA and EMA
• Proficiency in MS Office and familiarity with project planning tools