Note: The job is a remote job and is open to candidates in USA. Cabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases. The Director, Clinical Scientist will support the clinical development of CAR-T cell therapy programs and ensure the scientific and clinical integrity of trials through collaboration with various teams.
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
- Other related duties, as assigned
Skills
- 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
- 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
- Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
- Cell and gene therapy experience—particularly in CAR-T or T-cell–based modalities—strongly preferred; autoimmune disease experience highly desirable
Benefits
- Competitive benefits
- PTO
- Stock option plans
Company Overview