Director, Clinical Operations – Severe Asthma

Role Overview

• Provide strategic oversight and end-to-end operational leadership for global Phase 3 asthma studies and related development activities.
• Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives.
• Accountable for study timelines, budgets, resource allocation, quality metrics, and overall delivery.
• Lead scenario planning, risk forecasting, and mitigation strategies at the program level.
• Partner with Clinical Development leadership to inform portfolio-level planning and decision-making.
• Directly manage and develop Clinical Operations staff (e.g., Clinical Trial Leads and/or Clinical Trial Managers).
• Recruit, hire, onboard, and retain top talent to support late-stage clinical development.
• Set performance expectations, conduct evaluations, provide coaching, and support career development.
• Build a culture of accountability, collaboration, and operational excellence.
• Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC.
• Act as a primary point of accountability across internal stakeholders, CRO partners, and external vendors.
• Enable effective decision-making, timely escalation, and transparent communication across teams.
• Oversee global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives.
• Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs.
• Provide oversight of study budgets, vendor performance, and quality metrics.
• Establish performance metrics and drive continuous improvement across external partnerships.
• Lead inspection readiness strategy and support regulatory inspections.
• Drive proactive issue identification, risk management, and CAPA oversight.
• Contribute to Clinical Operations strategy, infrastructure development, and process optimization.
• Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies.
• Share best practices and help define standards across the clinical operations organization.

Requirements

• 12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry
• Significant experience leading global late-phase (Phase 3) studies
• Demonstrated success in direct people management, including hiring, performance management, and team development
• Proven ability to lead complex cross-functional teams and influence at senior leadership levels
• Strong expertise in CRO oversight, global regulatory environments, and inspection readiness
• Strategic thinker with strong operational execution skills
• Deep working knowledge of ICH/GCP and global clinical development regulations
• Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) strongly preferred

Tech Stack

• Google Cloud Platform

Benefits

• Competitive benefits package
• Annual bonus
• Equity compensation