Director, Clinical Operations

Responsibilities

• Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies
• Translate program strategy into executable operational plans aligned with regulatory and corporate objectives
• Manage study timelines, budgets, resource allocation, and quality metrics
• Directly manage and develop Clinical Operations staff, including hiring and coaching
• Lead multidisciplinary study teams across Data Management, Biostatistics, Safety, and Regulatory
• Oversee global study startup, site strategy, enrollment execution, and monitoring approaches
• Ensure compliance with ICH-GCP and global regulatory requirements
• Drive proactive issue identification, risk management, and CAPA oversight

Requirements

• 12–15+ years of clinical operations experience in pharmaceutical or biotechnology industry
• Significant experience leading global late-phase (Phase 3) studies
• Demonstrated success in direct people management and team development
• Proven ability to lead complex cross-functional teams
• Strong expertise in CRO oversight and inspection readiness
• Deep working knowledge of ICH/GCP and global clinical development regulations
• Bachelor's degree required; advanced degree (MS, MPH, PharmD, PhD) strongly preferred

Preferred Qualifications

• Late-phase respiratory or immunology therapeutic area experience
• Experience building or scaling clinical development functions in high-growth organizations

About the Company

Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. They integrate machine learning with large-scale experimentation to design proteins with defined biological intent, reducing the uncertainty and cost of developing protein-based medicines.