Director, Clinical Scientist

Role: The Director, Clinical Scientist supports the clinical development of Cabaletta Bio’s CAR-T cell therapies for autoimmune diseases, focusing on advancing programs from early proof-of-concept through late-stage pivotal studies. Responsibilities include designing and interpreting clinical trials, authoring key regulatory documents (e.g., protocols, INDs, CTAs), analyzing safety, efficacy, PK/PD data, and conducting literature reviews to inform strategies. They collaborate closely with Clinical Operations, Translational Medicine, Regulatory, and Biostatistics teams, serving as a scientific liaison across discovery and clinical phases. The role involves oversight of safety governance activities, presentation of data internally and externally, mentoring team members, and staying abreast of trends in cell/gene therapy and autoimmunity. Qualifications require an advanced degree (MS, Ph.D., Pharm.D., MD) with 4-5+ years in biotech, pharma, or academia, with experience in cell/gene therapies—ideally CAR-T—and autoimmune indications. The candidate must possess deep immunology knowledge, experience in clinical protocol development, strong data analysis skills, and excellent communication abilities. Therapeutic focus includes autoimmune diseases, with a preference for candidates familiar with cell and gene therapy modalities and early to late-stage development. The position is remote or based in Philadelphia, PA, with no specified travel requirements, and involves cross-functional collaboration, regulatory interactions, and scientific presentations.