Senior Director, Clinical Operations

Role: Senior Director of Clinical Operations overseeing global Phase I-IV trials in a biopharma focused on metabolic liver disease (MASH). Objectives include delivering complex clinical programs on time, within budget, and in compliance with regulatory standards. Responsibilities encompass strategic planning, trial execution from start-up to closeout, CRO/vendor oversight, risk management, and cross-functional collaboration with Clinical Development, Regulatory, Data Management, and other teams. The role involves leadership in study design inputs, regulatory submissions, vendor management, and establishing operational excellence within a fast-growing biotech. Qualifications: Bachelor's degree required; advanced degree (MS, PharmD, PhD) preferred; 15+ years of clinical trial operations experience, including management of Phase I-IV studies, preferably within biotech or pharma. Experience with first-in-human studies and metabolic or cardiovascular therapeutic areas is desirable. Skills include strong leadership, global trial expertise, regulatory knowledge (ICH-GCP, FDA, EMA), vendor oversight, project management, and financial acumen. The position involves global stakeholder engagement, vendor management, and operational strategy development. Work setup: not specified, but implied to be in a dynamic, high-performing environment.