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

Cabaletta Bio; Philadelphia (Philadelphia County); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Stock options

Job summary

Cabaletta Bio seeks a Director, Clinical Scientist to support CAR-T programs in autoimmune diseases. You will bridge discovery and clinical execution, shaping study design, data interpretation, and regulatory interactions at all development stages.

You will collaborate cross-functionally to ensure safety, efficacy, and data quality while contributing to strategy and regulatory readiness for BLA submission.

Qualifications

• Advanced degree in a relevant scientific discipline.
• 4-5+ years in clinical development within biotech/pharma or academia.
• CAR-T or T-cell–based modalities experience preferred.
• Deep understanding of T-cell biology, immunology, and translational science.
• Proven ability to author and review clinical protocols, reports, and regulatory documents.

Responsibilities

• Serve as key clinical science contributor for assigned CAR-T programs, supporting study design, execution, and interpretation across all phases.
• Lead or contribute to preparation of key clinical documents (protocols, amendments, ICFs, brochures, study reports, regulatory submissions).
• Review and interpret emerging clinical data (safety, efficacy, PK/PD) and identify trends with cross-functional input.
• Conduct literature reviews to inform study design and program strategy.
• Provide ongoing data review to ensure protocol alignment, patient safety, and data integrity.
• Collaborate with the Medical Monitor on safety findings, SAE review, and governance activities.
• Lead or support governance activities for Development, Executive, and Scientific Steering Committees; oversee external boards.
• Present scientific and clinical data internally and externally.
• Mentor study team members and contribute to vendor oversight.
• Maintain awareness of trends in cell and gene therapy and autoimmune diseases.

Skills

Strong communication

Cross-functional collaboration

Analytical rigor

Scientific judgment

Education

MS/PhD/PharmD/MD or equivalent

Job description

Cabaletta Bio seeks a Director, Clinical Scientist to support CAR-T programs in autoimmune diseases. You will bridge discovery and clinical execution, shaping study design, data interpretation, and regulatory interactions at all development stages.

You will collaborate cross-functionally to ensure safety, efficacy, and data quality while contributing to strategy and regulatory readiness for BLA submission.