Cabaletta Bio Inc.

This role supports the clinical development of CAR-T cell therapy programs in autoimmune diseases, contributing to the scientific integrity of trials from proof-of-concept through pivotal stages. Key duties include leading the preparation of essential clinical documents, analyzing emerging safety and efficacy data, and serving as a scientific link between discovery and clinical execution.

This role involves managing the end-to-end process for scientific publication planning, ensuring compliance, and collaborating with cross-functional teams to develop manuscripts, abstracts, and presentations. Responsibilities also include managing external vendor execution, budget oversight, and developing comprehensive scientific engagement and congress plans.

This key enterprise leader is responsible for setting the strategic direction, vision, and executional rigor for the company’s biostatistics and data management capabilities, serving as the principal statistical authority across the organization. Key duties include leading and developing the Biostatistics and Data Management functions, providing expert statistical input into clinical development strategy, and overseeing the development and execution of statistical analysis plans for all clinical studies.

The Senior In-House CRA supports the planning, execution, and oversight of clinical trials, acting as a key operational partner to clinical sites, CROs, and vendors. This role ensures high-quality trial conduct, strong external relationships, and inspection-ready documentation throughout the study lifecycle.

The Vice President of Regulatory Affairs will lead the global regulatory strategy and execution for an advanced cell therapy product development program, ensuring compliance and guiding interactions with global health authorities like the FDA and EMA. This role involves overseeing the preparation and submission of key regulatory documents such as INDs, CTAs, and BLAs/MAAs, while serving as a primary regulatory advisor to executive leadership.

This role involves serving as the Regulatory Lead for the pivotal program leading to BLA submission, responsible for developing and executing regulatory strategies to support the development and commercialization of cell therapy products. Key duties include managing all regulatory aspects through pivotal studies, preparing applications, managing health authority meetings, and ensuring compliance across global agencies like the FDA and EMA.

This physician leader will provide medical oversight and leadership for cell therapy programs in autoimmune diseases, collaborating across clinical operations, regulatory, and manufacturing functions while liaising with investigators and Health Authorities. Key duties include formulating study designs, leading protocol development, ensuring operational efficiency through CRO/vendor management, and participating hands-on in all aspects of clinical study conduct, data review, and reporting.