Associate Director, Clinical Study Lead

Role: Senior/Associate Director-level Regional Clinical Study Lead responsible for operational management of global clinical studies within specified regions or countries. Objectives: ensure study delivery on time, within scope, quality, and budget, while maintaining compliance with ICH-GCP and regulatory standards. Responsibilities: lead study planning, start-up, conduct, and close-out; serve as the primary Clinical Operations contact; develop study execution plans, oversee site feasibility, qualification, and engagement; contribute to protocol and study document development; oversee CRO/vendor selection, performance, and issue resolution; monitor KPIs, quality metrics, and risks; support audit and inspection readiness; and mentor junior team members. Qualifications: bachelor’s degree or higher in relevant sciences, with 7+ years of pharma/Biotech/CRO experience, including at least 6 years in clinical research managing Phase 1-3 studies or regional components. Skills: deep knowledge of ICH-GCP, regulatory requirements (FDA, EMA), clinical study management, CRO oversight, risk management, and cross-functional collaboration. Preferred: experience in outsourced models, strong communication skills, and ability to work independently in a global matrix environment. High-Value: experience with multi-region global studies, clinical phase 1-3, regulatory compliance, and CRO oversight. Work setup: travel domestically and internationally as needed.