Director, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic guidance and comprehensive operational leadership for global Phase 3 studies and associated development activities.

• Convert program strategy into detailed, actionable operational plans that align with regulatory, scientific, and corporate goals.

• Take ownership of study timelines, budgets, resource distribution, quality metrics, and overall project delivery.

• Lead scenario analysis, risk forecasting, and mitigation strategies at the program level.

• Collaborate with Clinical Development leadership on portfolio-level planning and decision-making processes.

• Directly oversee and nurture Clinical Operations staff.

• Recruit, hire, onboard, and retain talented individuals.

• Establish performance expectations, conduct evaluations, provide coaching, and support career progression.

• Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC.

• Coordinate with internal stakeholders, CRO partners, and external vendors.

• Supervise global study startup, site strategy, enrollment execution, monitoring strategies, and patient engagement initiatives.

• Ensure adherence to ICH-GCP, global regulatory standards, and internal SOPs.

• Oversee study budgets, vendor performance, and quality metrics.

• Establish performance metrics and promote continuous improvement across external partnerships.

• Lead inspection readiness strategies and support regulatory inspections.

• Drive issue identification, risk management, and CAPA oversight.

• Contribute to the development of Clinical Operations strategies, infrastructure, and process optimization.

• Advocate for innovation in trial execution, including digital solutions, decentralized methods, and patient-focused strategies.

• Share best practices and establish standards throughout the clinical operations organization.

⛳️ Requirements

• 12–15+ years of experience in clinical operations within the pharmaceutical or biotechnology sectors.

• A Bachelor’s degree is required.

• Significant experience in leading global late-phase (Phase 3) studies.

• Proven success in direct management of personnel, including hiring, performance management, and team development.

• Demonstrated ability to lead complex cross-functional teams and influence senior leadership.

• Strong expertise in CRO oversight, global regulatory landscapes, and inspection readiness.

• Strategic thinker with robust operational execution capabilities.

• Extensive knowledge of ICH/GCP and global clinical development regulations.

🏝️ Benefits

• Annual bonus.

• Equity compensation.

• Competitive benefits package.