Associate Director, Clinical Trial Lead – Clinical Operations

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Cabaletta Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies to treat autoimmune diseases. Using its CABA® (Cabaletta Approach to B cell Ablation) platform, the company is advancing rese-cel, a fully human CD19 CAR T cell candidate with a 4-1BB co-stimulatory domain, in multiple RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. Cabaletta aims to deliver deep, durable, potentially curative responses by transiently eliminating B cells to reset immune tolerance, and emphasizes patient-centered development and broad indication expansion across rheumatology, dermatology, and neurology.

📋 Description

• Lead planning, execution, management, and delivery of assigned regional and global clinical trials from protocol development through study conduct, closeout, analysis, and reporting. • Provide operational leadership and oversight for study startup, site activation, patient recruitment and enrollment, monitoring, protocol deviations, data review and cleaning, database lock readiness, and closeout. • Serve as primary operational 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 selection, onboarding, management, and performance of CROs and vendors against timelines, quality, contracts, and budgets. • Build relationships with investigational sites, investigators, study coordinators, monitors, and vendor partners. • Develop, author, review, and approve trial documents and operational plans, including protocols, 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. • Track study progress using project management methodologies and operational metrics; identify risks and implement mitigation strategies. • Drive operational innovation and process improvements, including remote monitoring and clinical supply management. • Ensure compliance with ICH-GCP, applicable regulations, and company SOPs; manage quality issues, CAPAs, inspection readiness, audits, and regulatory inspections. • Perform retained in-house operational activities as needed. • Mentor, develop, and/or directly manage In-house CRAs, contingent workers, and other assigned personnel. • Support departmental initiatives, continuous improvement, and clinical operations SOP development or revision.

🎯 Requirements

• 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 in biotechnology or pharmaceutical companies. • Proven leadership of complex clinical studies, including 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 matrix management across regulatory affairs, data management, safety/pharmacovigilance, medical monitoring, biostatistics, clinical supply, and medical writing. • Ability to drive operational excellence, solve complex challenges, and influence stakeholders at all levels. • Excellent leadership, project management, communication, and organizational skills. • Willingness to travel up to 10% as required. • Cell/gene therapy or oncology experience preferred. • Must be authorized to work in the United States; visa sponsorship requirements are addressed in the application.

🏖️ Benefits

• Competitive benefits • PTO • Stock option plans • Commitment to employee well-being and continuous growth • Great Place to Work-Certified™ company