Director, Clinical Scientist

About the role

Cabaletta Bio is recruiting a Director, Clinical Scientist to support the clinical development of its CAR-T cell therapy programs in autoimmune diseases. The position can be remote or based at the Philadelphia, PA headquarters. It works closely with Clinical Operations, Translational Medicine, Regulatory and Biostatistics to ensure high-quality data and alignment toward a successful BLA submission.

Key responsibilities

• Serve as a key clinical science contributor for assigned CAR-T programs, partnering with the Medical Director on study design, execution and interpretation.
• Lead or contribute to clinical documents such as protocols, amendments, informed consent forms, investigator brochures, clinical study reports and regulatory submissions (INDs, CTAs, DSURs, BLAs/MAAs).
• Review and interpret clinical data (safety, efficacy, PK/PD) and conduct literature and competitive landscape reviews.
• Provide ongoing data review to ensure study conduct meets protocol, patient safety and data integrity standards.
• Collaborate with the Medical Monitor on safety and efficacy findings, SAE review and safety governance.
• Lead or support steering committee and external board (e.g., DSMB) governance, and present data internally and externally.
• Mentor study team members and contribute to vendor oversight.

Required profile

• Advanced degree (MS, Ph.D., Pharm.D., M.D. or equivalent) in a relevant scientific discipline preferred.
• 4-5+ years of clinical development experience in biotech, pharma or academia, with leadership through early and late stage.
• Cell and gene therapy experience, especially CAR-T or T-cell modalities, strongly preferred; autoimmune disease experience highly desirable.
• Proven ability to write and review clinical protocols, study reports and regulatory documents in line with ICH-GCP.
• Strong communication, organization and scientific judgment.

Required skills

• Deep understanding of T-cell biology, immunology and translational science.
• Analyzing complex clinical data and conducting literature reviews.

What we offer

• Health and retirement benefits.
• PTO.
• Stock option plans.