Director, Clinical Scientist
Cabaletta Bio
August 15, 2026
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Position Description
- This role can be remote or based out of our Philadelphia, PA headquarters.
Director, Clinical Scientist
Key Responsibilities
- Serve as a key clinical science contributor for assigned CAR-T programs, partnering with the Medical Director and Clinical Development team to support study design, execution, and interpretation across all phases.
- Lead or contribute to preparation of key clinical documents (protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions such as INDs, CTAs, DSURs, BLAs/MAAs).
- Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends/issues and support timely resolution.
- Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy.
- Provide ongoing data review to ensure protocol adherence, patient safety, and data integrity.
- Collaborate with the Medical Monitor for key safety/efficacy findings, including SAE review, narrative development, and safety governance.
- Lead/support governance activities (materials for Development, Executive, and Scientific Steering Committees; oversight of DSMB and adjudication committees).
- Contribute to/present clinical data internally and externally (investigator meetings, scientific conferences, regulatory interactions).
- Serve as the clinical science representative on cross-functional teams; provide scientific/strategic input.
- Mentor study team members; contribute to vendor oversight to ensure quality and rigor of clinical deliverables.
- Stay current on scientific/regulatory trends in cell/gene therapy and autoimmune diseases; integrate innovations into 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 in biotech/pharma/academia, with leadership through early and late-stage development.
- Cell/gene therapy experience—especially CAR-T or T-cell modalities—strongly preferred; autoimmune disease experience highly desirable.
- Deep understanding of T-cell biology, immunology, and translational science for cellular therapy.
- Proven ability to author/critically review clinical protocols, study reports, and regulatory documents with ICH-GCP and global regulatory standards.
- Strong skills in analyzing complex clinical data; conducting literature reviews; synthesizing insights for program strategy.
- Exceptional judgment, attention to detail, and analytical rigor.
- Strong communication/collaboration across cross-functional teams, investigators, and external experts.
- Highly organized; able to manage multiple priorities in a fast-paced environment.
- This role can be remote or based out of our Philadelphia, PA headquarters.
Director, Clinical Scientist
Key Responsibilities
- Serve as a key clinical science contributor for assigned CAR-T programs, partnering with the Medical Director and Clinical Development team to support study design, execution, and interpretation across all phases.
- Lead or contribute to preparation of key clinical documents (protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions such as INDs, CTAs, DSURs, BLAs/MAAs).
- Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends/issues and support timely resolution.
- Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy.
- Provide ongoing data review to ensure protocol adherence, patient safety, and data integrity.
- Collaborate with the Medical Monitor for key safety/efficacy findings, including SAE review, narrative development, and safety governance.
- Lead/support governance activities (materials for Development, Executive, and Scientific Steering Committees; oversight of DSMB and adjudication committees).
- Contribute to/present clinical data internally and externally (investigator meetings, scientific conferences, regulatory interactions).
- Serve as the clinical science representative on cross-functional teams; provide scientific/strategic input.
- Mentor study team members; contribute to vendor oversight to ensure quality and rigor of clinical deliverables.
- Stay current on scientific/regulatory trends in cell/gene therapy and autoimmune diseases; integrate innovations into 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 in biotech/pharma/academia, with leadership through early and late-stage development.
- Cell/gene therapy experience—especially CAR-T or T-cell modalities—strongly preferred; autoimmune disease experience highly desirable.
- Deep understanding of T-cell biology, immunology, and translational science for cellular therapy.
- Proven ability to author/critically review clinical protocols, study reports, and regulatory documents with ICH-GCP and global regulatory standards.
- Strong skills in analyzing complex clinical data; conducting literature reviews; synthesizing insights for program strategy.
- Exceptional judgment, attention to detail, and analytical rigor.
- Strong communication/collaboration across cross-functional teams, investigators, and external experts.
- Highly organized; able to manage multiple priorities in a fast-paced environment.