Associate Director, Clinical Operations Lead – Asthma

Job Description: • Serve as the operational lead for global Phase 3 asthma studies • Develop overall study strategy, timelines, and operational plans • Lead scenario planning, risk assessment, and proactive mitigation efforts • Review and approve key trial documents • Lead and coordinate multidisciplinary study teams • Act as the central point of accountability across stakeholders • Enable effective communication, decision-making, and timely issue escalation • Oversee study start-up, site identification, enrollment strategy, monitoring plans • Ensure study conduct follows ICH-GCP, SOPs, and global regulatory requirements • Manage study budget, vendor performance, timelines, and quality metrics • Assist in audit preparation and ensure corrective and preventive actions • Partner closely with data management and biostatistics for data quality • Drive inspection readiness and continuous study health assessments • Provide operational oversight of CROs and ensure deliverables meet expectations Requirements: • 8–12+ years of clinical operations experience • At least 6 years of direct leadership in Late Phase global studies • Late Phase Respiratory or immunology therapeutic area experience • Strong leadership, strategic planning, communication, and problem-solving skills • Ability to work independently while orchestrating complex cross-functional execution • Pharmaceutical industry experience and working knowledge of ICH/GCP regulations • Bachelor's degree required; advanced degree (MS, MPH, PharmD, PhD) preferred. Benefits: • Competitive benefits package • Annual bonus • Equity compensation Apply Now Apply Now