Senior Director of Clinical Operations

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