Associate Director, Clinical Trial Lead, Clinical Operations

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA™ platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases.

About The Position

Reporting to the Director, Clinical Operations, the Associate Director, Clinical Trial Lead, Clinical Operations will be a proactive, self-starter responsible for providing oversight and support to clinical operations vendors and teams in planning, execution, data management, and close-out of assigned clinical studies with a focus on quality and compliance. This individual will be a key contributor to clinical development planning, analysis, and reporting of data for assigned programs, including protocol development, data management plans, statistical analysis plans, and safety reporting plans. Additionally, this role will contribute to Clinical Operations departmental continual process improvement initiatives related to study management, information and tracking systems, metrics, and the development or enhancement of clinical operations SOPs.

Responsibilities

• Lead the planning, execution, management, and delivery of assigned regional and global clinical trials from protocol development through study conduct, closeout, analysis, and reporting, ensuring alignment with development and regulatory strategies.
• Provide operational leadership and oversight for all clinical trial activities, including study startup, site activation, patient recruitment and enrollment, monitoring oversight, protocol deviation management, data review and cleaning, database lock readiness, and study closeout.
• Serve as the primary operational contact and liaison among internal cross-functional teams and external stakeholders, including CROs, clinical sites, vendors, regulatory affairs, quality assurance, safety, data management, medical writing, translational research, clinical supply, and document management.
• Oversee the selection, onboarding, management, and performance of CROs and vendors, ensuring delivery against study timelines, quality expectations, contractual obligations, and budget requirements.
• Build and maintain strong relationships with investigational sites, investigators, study coordinators, monitors, and vendor partners to support successful study execution.
• Develop, author, review, and approve key trial documents and operational plans, including protocols, protocol amendments, informed consent forms, study manuals, study plans, regulatory responses, and clinical study reports.
• Manage study budgets, forecasts, work orders, change orders, and financial performance while ensuring efficient use of resources.
• Apply project management methodologies and operational metrics to track study progress, identify risks, implement mitigation strategies, and facilitate informed decision-making.
• Drive innovative operational approaches and process improvements, including remote monitoring strategies and optimized clinical supply management.
• Ensure compliance with ICH-GCP guidelines, applicable regulations, and company SOPs; proactively manage quality issues, CAPAs, inspection readiness activities, audit activities, and regulatory inspections.
• Perform operational activities that are retained in-house and not outsourced to vendors, as needed.
• Mentor, develop, and/or directly manage In-house CRAs, contingent workers, and other assigned personnel while fostering a collaborative, high-performance culture.
• Support departmental initiatives, continuous improvement efforts, and the development or revision of clinical operations procedures and SOPs.

Qualifications & Experience

• BA or BS degree in a scientific or healthcare-related discipline required.
• 8-10+ years of clinical research experience, including significant global clinical trial management experience within biotechnology or pharmaceutical company.
• Proven leadership of complex clinical studies, including oversight of budgets, timelines, vendors, resources, and risk management.
• Extensive experience managing CROs, external vendors, and cross-functional teams in a matrix environment.
• Strong knowledge of clinical trial operations, drug development, ICH-GCP, regulatory requirements, and inspection readiness.
• Experience across early and late-phase clinical development.
• Broad knowledge of managing within a matrix management with cross-functional clinical development disciplines, including regulatory affairs, data management, safety/pharmacovigilance, medical monitoring, biostatistics, clinical supply, and medical writing.
• Demonstrated ability to drive operational excellence, solve complex challenges, and influence stakeholders at all levels.
• Excellent leadership, project management, communication, and organizational skills.
• Cell/Gene therapy or oncology experience preferred.
• Willingness to travel up to 10% as required.

Benefits

• Competitive benefits
• Paid time off (PTO)
• Stock option plans

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