Senior Director, Clinical Operations

Role: Senior Director of Clinical Operations leading global Phase I-IV clinical trials for biopharma in metabolic liver disease, focusing on Rezdiffra (resmetirom) for MASH. Responsibilities: develop and execute operational strategies, oversee trial start-up to closeout, manage CRO/vendor relationships, ensure regulatory compliance (ICH-GCP, FDA, EMA), and partner cross-functionally on study design, feasibility, and regulatory submissions. Lead and mentor Clinical Operations teams, build scalable processes, monitor trial performance through KPIs, and support inspection readiness. Qualifications: Bachelor’s degree required; MS, PharmD, PhD preferred. 15+ years of progressive clinical trial operations experience, including managing early and late-phase studies, with preference for biotech environments and metabolic/cardiovascular areas. Demonstrated success in global trial oversight, vendor management, and regulatory compliance. High-value: Experience with first-in-human studies, Phase I-III, and biologics or small molecules in metabolic indications; familiarity with core systems like CTMS, EDC, IRT; leadership in fast-paced, growth-stage biotech settings. Collaboration: Partnering with Clinical Development, Regulatory, Data Management, and Quality teams. Work setup: Full-time, with competitive salary ($262K-$307K), equity, and comprehensive benefits.