Pioneering Medicines: Associate Director / Director, Clinical Operations

Role: Associate Director or Director of Clinical Development Operations overseeing early-phase (Phase 1/2) clinical programs in biopharma, with a focus on innovative treatments for serious diseases. Responsibilities: lead end-to-end clinical trial management including study start-up, execution, vendor and site oversight, data quality, and regulatory compliance; collaborate with multidisciplinary teams on trial design, operational planning, and regulatory milestones; manage budgets and timelines; develop clinical documentation; and contribute to organizational process improvements. Qualifications: Bachelor's degree in life sciences or related field; 10+ years industry experience with at least 5 years in clinical trial management; proven expertise in early-phase (FIH, IND/CTA) studies, vendor selection, and managing global, multi-site trials; strong knowledge of ICH-GCP, FDA, EMA regulations; proficiency with clinical systems (EDC, CTMS, TMF); excellent cross-functional collaboration skills; experience in metabolic diseases, obesity, oncology, or rare diseases preferred. Work setup involves domestic and international travel (up to 10%), with a focus on high-ownership, lean environments. High-Value: early-phase clinical development, CRO/vendor management, cross-functional leadership, regulatory compliance, and therapeutic areas including metabolic, oncology, or rare diseases.