Director, Clinical Scientist — CAR-T Autoimmunity (Remote)

Cabaletta Bio Inc.; Philadelphia (Philadelphia County); Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

PTO

Stock options

Competitive benefits

Job summary

Director, Clinical Scientist at Cabaletta Bio Inc. offers remote work or based in Philadelphia to lead clinical development for autoimmune CAR-T programs.

You will ensure data integrity and collaborate with Clinical Operations, Translational Medicine, Regulatory, and Biostatistics to support high-quality trials and a potential BLA submission. You will mentor teams, review safety and efficacy data, author protocols and regulatory documents, and contribute to governance and external scientific

Qualifications

• Experience leading clinical programs from proof-of-concept through pivotal studies.
• Strong background in autoimmune diseases and CAR-T or T-cell therapies.
• Ability to author and critically review clinical protocols, study reports, and regulatory documents.

Responsibilities

• Serve as clinical science contributor for assigned CAR‑T programs, supporting study design and interpretation across all phases.
• Lead preparation of clinical documents: protocols, amendments, ICFs, brochures, study reports, and regulatory submissions (INDs/CTAs/DSURs/BLAs/MAAs).
• Review emerging safety/efficacy data and identify trends for cross-functional action.
• Conduct literature reviews to inform study design and program strategy.
• Mentor team members and support external governance committees (DSMBs, etc.).

Skills

Clinical development leadership

CAR-T / T-cell therapies

Immunology & translational science

Regulatory strategy

Data interpretation

Cross-functional collaboration

Mentoring

Education

Advanced degree (MS, PhD, MD, or equivalent)

Tools

ICH-GCP familiarity

Job description

Director, Clinical Scientist at Cabaletta Bio Inc. offers remote work or based in Philadelphia to lead clinical development for autoimmune CAR-T programs.

You will ensure data integrity and collaborate with Clinical Operations, Translational Medicine, Regulatory, and Biostatistics to support high-quality trials and a potential BLA submission. You will mentor teams, review safety and efficacy data, author protocols and regulatory documents, and contribute to governance and external scientific