Job Title: Associate Director, Clinical Trial Management

Work Location: New York County, New York

Summary:

The Associate Director, Clinical Trial Management provides strategic and operational leadership for the execution of complex clinical studies, ensuring alignment with program objectives and regulatory standards. This role emphasizes sponsor oversight, cross-functional collaboration, and a commitment to quality and continuous improvement, particularly in gene therapy or Car-T clinical trials.

Responsibilities:

• Design and execute operational strategies to meet clinical study and development objectives.
• Direct daily management of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
• Collaborate with cross-functional teams to ensure seamless study execution and alignment with regulatory and safety requirements.
• Oversee and manage external vendors, ensuring performance, compliance, and contractual obligations are met.
• Develop and monitor study budgets, working closely with finance and vendor partners for accurate forecasting and reconciliation.
• Identify operational risks proactively and implement mitigation strategies to safeguard study integrity and timelines.
• Leverage digital and analytics solutions to generate operational insights through use of study dashboards/metrics, innovative AI-enabled approaches/tools and data to solve execution hurdles, including with vendors (e.g., ICD codes and prescription/script data), to support patient identification and recruitment strategies; contribute to implementation of digital recruitment platforms and decentralized/hybrid trial approaches, as appropriate
• Contribute to protocol operationalization, including feasibility assessments, site selection, monitoring strategies, and recruitment planning.
• Maintain comprehensive sponsor oversight documentation and ensure audit and inspection readiness at all times.

Qualifications:

• Advanced degree in life sciences preferred.
• At least 10 years of clinical trial management experience in biotech or pharmaceutical environments.
• Strong knowledge of ICH/GCP guidelines and relevant regulatory requirements.
• Experience in site monitoring is strongly preferred.
• Demonstrated ability to manage global studies and oversee CRO partnerships.
• Experience working with sites and/or vendors in Brazil or South America.
• Proven skills in managing complex protocols, budgets, timelines, and vendor relationships.
• Experience in operational planning across all phases of clinical study execution.
• Excellent communication and stakeholder management abilities.
• Analytical and problem-solving skills with a detail-oriented, collaborative approach.
• Willingness to travel domestically and internationally as needed.
• Gene Therapy or Car-T experience required.

Published Category: Clinical Operations & Development