Director, Clinical Scientist

About the role

The Director, Clinical Scientist at Cabaletta Bio will play a key role in supporting the clinical development of the company's CAR-T cell therapy programs in autoimmune diseases. This individual will contribute to the scientific and clinical integrity of trials from early proof-of-concept through late-stage pivotal studies, working closely with Clinical Operations, Translational Medicine, Regulatory, and Biostatistics to help ensure high-quality data and alignment toward a successful BLA submission.

Responsibilities

• Serve as a key clinical science contributor for assigned CAR-T programs, partnering with the Medical Director and other Clinical Development team members to support study design, execution, and interpretation across all phases of clinical development.
• Lead or contribute to the preparation of key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs, BLAs/MAAs).
• Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration.
• Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy.
• Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations.
• Collaborate with the Medical Monitor to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities.
• Lead or support governance activities, including preparation and presentation of materials for Development, Executive, and Scientific Steering Committees, as well as oversight of external boards (e.g., DSMB, adjudication committees).
• Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, regulatory interactions).
• Serve as the clinical science representative on cross-functional development and study teams, providing scientific and strategic input to ensure cohesive execution.
• Mentor study team members and contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables.
• Maintain awareness of emerging scientific and regulatory trends in cell and gene therapy and autoimmune diseases to integrate innovations into development strategy.

Qualifications

• Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
• 4-5+ years of clinical development experience within biotech, pharmaceutical, or academic settings, with demonstrated leadership in advancing programs through early and late-stage development
• Cell and gene therapy experience—particularly in CAR-T or T-cell–based modalities—strongly preferred; autoimmune disease experience highly desirable
• Deep understanding of T-cell biology, immunology, and translational science principles relevant to cellular therapy
• Proven ability to author and critically review clinical protocols, study reports, and regulatory documents, ensuring scientific integrity and compliance with ICH-GCP and global regulatory standards
• Demonstrated skill in analyzing complex clinical data, conducting literature reviews, and synthesizing insights to inform program strategy
• Exceptional scientific judgment, attention to detail, and analytical rigor
• Strong communication and collaboration skills, with the ability to influence and partner effectively across cross-functional teams, investigators, and external experts
• Highly organized with the ability to manage multiple priorities in a fast-paced, evolving environment

Skills

• Expertise in T-cell biology, immunology, and translational science principles relevant to cellular therapy
• Ability to author and critically review clinical protocols, study reports, and regulatory documents
• Strong data analysis and interpretation skills
• Effective communication and collaboration skills

Benefits

• Competitive benefits
• PTO
• Stock option plans

Pay

Commensurate with experience

Schedule

Flexible