Director Of Clinical Operations

Director of Clinical Operations Overview

• The Director of Clinical Operations will lead strategic and operational efforts for neuroscience clinical development programs.
• Provide leadership in planning, execution, and oversight of global clinical trials with scientific rigor and operational excellence.
• Collaborate with cross-functional teams to ensure alignment with clinical development objectives and regulatory requirements.
• Lead and develop a high-performing team, fostering innovation and continuous improvement in clinical trial execution.
• Ensure effective oversight of clinical sites, CROs, and vendors to maintain quality and accountability.
• Drive operational metrics, KPIs, and performance reporting to support program success.
• Represent Clinical Operations in governance forums, providing updates on program status and risk mitigation strategies.
• Support inspection readiness and compliance initiatives to ensure adherence to global regulations.

Director of Clinical Operations Key Responsibilities & Duties

• Provide strategic leadership for neuroscience clinical development programs, ensuring delivery of clinical studies per development plans.
• Define and implement clinical operations strategies, including study design, timelines, budgets, and risk mitigation.
• Lead and develop clinical operations teams, fostering collaboration and accountability.
• Ensure oversight of clinical sites, CROs, and vendors, maintaining quality and compliance.
• Collaborate with cross-functional teams to resolve operational issues and align program objectives.
• Monitor operational metrics and drive continuous improvement initiatives.
• Support regulatory inspections and quality initiatives to ensure readiness and compliance.
• Represent Clinical Operations in governance forums, providing updates on risks and milestones.
• Identify opportunities for innovation and process improvements in clinical trial execution.

Director of Clinical Operations Job Requirements

• Bachelor’s degree in science or related field; advanced degree preferred.
• Minimum 10 years of experience in clinical operations within the pharmaceutical or biotechnology industry.
• Proven expertise in neuroscience, CNS, psychiatry, or neurodegenerative diseases.
• Experience managing global clinical trials across all phases (I-IV).
• Strong leadership skills with a focus on team development and operational excellence.
• Advanced knowledge of ICH/GCP and applicable global regulations.
• Proficiency in clinical trial strategy, budget management, and vendor oversight.
• Excellent communication and problem-solving skills, with ability to influence senior leaders.
• Experience supporting regulatory inspections and implementing quality initiatives.