Associate Director, Clinical Operations Study Lead

Role Overview

• Provides strategic and operational leadership for one or more complex clinical studies, ensuring successful delivery through the study lifecycle (planning to execution) ensuring adherence to timelines, budgets, and quality standards.
• Develops executable study plans and milestones. Establishes and maintains clinical study timelines.
• Utilizes operational data and metrics to drive high-quality planning processes and operational execution. Monitors the same to drive overall performance and risk management.
• Maintains a comprehensive overview of study status, proactively communicating progress, risks, and mitigation strategies to stakeholders.
• Leads/partners in the development and/or QC review of key study documentation (e.g, study protocols, informed consents, monitoring plans, operational manuals)
• Drives operational initiatives key to successful study execution including but not limited to site identification/qualification, site activation strategy, site performance management, overall enrollment success (including mitigation/rescue actions as needed).
• Ensures clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines and internal quality standards.
• Supports or leads aspects of audit and inspection readiness and risk mitigation initiatives, including root cause analysis and CAPA development/closure for operational findings on assigned studies.
• Actively contributes to the advancement of department and organizational initiatives and processes.
• Leads study and/or project team(s), including effectively partnering with colleagues from other disciplines. (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators, alliance partners) to ensure seamless trial execution.
• Participate in the mentorship of clinical operations staff.
• Contributes to the development and implementation of novel clinical operations activities and methods in cell therapy.

Requirements

• Bachelor’s degree in life sciences or related field
• 7+ years’ experience in clinical operations within the pharmaceutical, biotech and or CRO setting including at least 2 years in a study or team leadership role in a pharma or biotech company.
• Experience supporting both early and late-stage clinical studies. Preference for experience with BLA-enabling trials.
• Demonstrated success managing complex clinical studies in global settings; strong preference for cell/gene therapy or biologics experience; therapeutic area experience in neurology and/or ophthalmology preferred.
• Excellent knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICH-GCP, FDA, EMA).
• Strong vendor management skills and experience with complex outsourcing and partnership models
• Proven financial acumen. Experience managing within a study budget, managing and reporting on change order status
• Exceptional verbal and written communication and stakeholder management skills . Track record of developing and delivering high quality materials and updates for leadership forums.
• Demonstrated ability to effectively collaborate with internal and external stakeholders in a highly matrixed setting
• Ability to thrive in a fast-paced, matrixed, and innovative environment.

Tech Stack

• Google Cloud Platform