Associate Director, Clinical Study Lead

Role: Senior/Associate Director-level Clinical Study Lead responsible for operational management of global clinical studies across regions or countries. Objectives: ensure study delivery on time, within budget, and in compliance with regulations and quality standards. Responsibilities: lead planning, start-up, conduct, monitoring, and close-out; serve as principal Clinical Operations contact; develop execution strategies, oversee site feasibility and activation, manage CRO/vendor performance, and ensure inspection readiness; support audits, documentation, and study reporting; mentor junior team members; act as back-up study lead. Qualifications: bachelor's in life sciences or related field; 7+ years in pharma, biotech, or CRO, with at least 6 years in clinical research; experience managing Phase 1-3 studies, including start-up through close-out; proficient in managing outsourced models and regulatory compliance (ICH-GCP, FDA, EMA); strong organizational, communication, and risk management skills. High-Value: global/regional scope, Phase 1-3, CRO oversight, regulatory compliance, detailed study management, strong vendor oversight, and cross-functional stakeholder engagement. Work setup: likely hybrid or remote with domestic and international travel as needed.