Director, Clinical Site and Trial Operations

Clinical Operations Leadership  

• Build, lead, and mentor a high-performing CSTO team.  

• Establish a strategic vision for the function and implement operational best practices and SOPs in collaboration with cross-functional teams.  

• Support long-term resource planning and department growth for a rapidly expanding clinical portfolio.  

• Champion a culture of accountability, collaboration, and continuous improvement.  

Vendor and CRO Management  

• Oversee day-to-day management of vendors including CROs and central labs.  

• Ensure vendor compliance with contractual obligations, timelines, and performance metrics for site management.  

• Contribute to governance, vendor oversight, and quality management and improvement processes for effective trial execution.  

Quality Assurance and Regulatory Compliance  

• Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements.  

• Partner with Quality Assurance on inspection readiness and corrective actions as needed.  

• Drive operational excellence to ensure data integrity and consistent trial conduct.  

Cross-Functional Collaboration  

• Align cross-functionally on program objectives and execution plans.  

• Represent CSTO in l governance meetings and provide operational input into strategic decisions.  

• Support regulatory submissions (INDs, NDAs, BLAs) and health authority interactions as needed.  

Budget and Resource Management  

• Support Project Delivery in developing, managing, and forecasting Clinical trial budgets, aligned with corporate priorities and program timelines.  

• Oversee CTSO resource allocation to optimize team performance and deliver milestones on time.  

• Maintain financial oversight of site budgets and site management and monitoring activities, whether conducted by in-house teams or outsourced.  

Qualifications

• Bachelor’s degree with 12+ years of clinical operations experience within the biotechnology or pharmaceutical industry; Master’s degree with 10+ years; or Ph.D. with 8+ years managing clinical operations in oncology or related therapeutic area; or equivalent experience.  

Knowledge and Skills

• Deep understanding of clinical development processes, trial design, and global regulatory frameworks.  

• Ability to lead global clinical trials across multiple development phases (I–III).  

• Expertise in ICH-GCP, FDA, and EMA regulations.  

• Strong operational acumen and project management skills.  

• Proven ability to lead cross-functional initiatives and influence stakeholders at all organizational levels.  

• Ability to build, lead, and mentor high-performing CSTO teams.  

• Exceptional communication, negotiation, and interpersonal skills.  

• Analytical mindset with a strategic approach to problem-solving and decision-making.  

• Ability to manage multiple complex projects in a dynamic environment.  

• High degree of professionalism, adaptability, and accountability.