Senior Director, Clinical Operations

Role: Senior Director of Clinical Operations overseeing strategic clinical trial management for Certara, with a focus on early-phase (Phase 1) studies and CRO/vendor oversight. Responsibilities: lead clinical operations, vendor selection, study start-up, site training, quality audits, and regulatory compliance; develop study documents; manage project timelines, budgets, and vendor relationships; ensure adherence to GxP, ICH/GCP, and applicable regulations; contribute to quality systems and training; collaborate with sponsors and stakeholders on project goals. Requirements: Bachelor's degree in life sciences or related field; 15+ years in CRO or pharmaceutical industry, with at least 5 years in early development and Phase 1 operations; strong leadership and team management skills; extensive knowledge of clinical trial conduct, regulatory standards, and vendor management; experience in clinical supply and data management; proficiency in project planning tools and MS Office. Preferred: management of multi-disciplinary teams, SOP development, and international regulatory experience. HighValue: Phase 1 drug development, early clinical trial oversight, CRO/vendor management, regulatory compliance, and biopharma project leadership. WorkSetup: likely hybrid or onsite with significant stakeholder interaction.