Associate Director, Clinical Data Management

Associate Director, Clinical Data Management (Remote) Philadelphia, PA 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. The CARTA strategy, or Chimeric Antigen Receptor T cells for Autoimmunity, is designed to potentially reset the immune system by causing transient B cell depletion with early academic clinical data suggesting the potential of this strategy to transform treatment in patients with SLE and the possibility of cures in rheumatoid arthritis, myositis, and systemic sclerosis, among others. Our lead product candidate using the CARTA strategy is CABA-201, 4-1BB-containing CD19-CAR T designed specifically to treat patients with autoimmune diseases with high unmet need, including systemic lupus erythematosus (SLE), myositis, systemic sclerosis, and generalized myasthenia gravis, and which uses a CD-19 binder that has an encouraging clinical tolerability profile. In addition to our CARTA candidate, CABA-201, we have a clinical-stage pipeline of Chimeric AutoAntibody Receptor T (CAART) cells targeted to the cells responsible for autoantibody-mediated autoimmune diseases. Cabaletta Bio’s headquarters are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter). Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work® About the Position: The Associate Director, Clinical Data Management will serve as a senior Data Management Lead and strategic data management leader across assigned clinical studies. This role will provide end-to-end leadership from protocol review and study start-up through database lock, regulatory submission support, long-term follow-up, and archival, while ensuring high-quality, analysis-ready clinical data. Responsibilities: - Serve as senior Data Management Lead for assigned clinical studies across multiple phases, providing end-to-end leadership from protocol review through database lock, long-term follow-up, and archival. - Review protocols and study strategies to ensure feasible, compliant, and effective data collection. - Lead EDC, CRF, edit check, query logic, user requirements, and CRF completion guideline development. - Oversee external data integrations, transfers, reconciliation, medical coding, and validation. - Develop and maintain data management plans, database specifications, validation records, UAT documentation, and data review plans. - Lead cross-functional data review and align stakeholders on quality, timelines, and risk mitigation. - Oversee CROs and vendors, including selection, performance, quality, timelines, budgets, and change orders. - Drive study and program milestones, proactively identifying risks and implementing solutions. - Lead database testing, UAT, data cleaning, coding, reconciliation, database lock, and archival. - Review data listings and support analyses, safety monitoring committees, endpoint adjudication, and submissions. - Support regulatory submissions, health authority responses, inspection readiness, and audits. - Ensur