Cabaletta Bio · 3 days ago
Sr. Director, Clinical Scientist
United States
Full-time
Remote
Director/Executive
7+ years expCabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases. The Sr. Director, Clinical Scientist will shape the clinical development strategy for CAR-T cell therapy programs, ensuring scientific and clinical integrity throughout trials and collaborating with various departments to support successful submissions.
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Responsibilities
Serve as the clinical science lead for assigned CAR-T programs, partnering with the Medical Director on the design, execution, and interpretation of clinical studies across all phases of development
Author and oversee 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
Qualification
Required
Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
7+ 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
Benefits
Competitive benefits
PTO
Stock option plans
Company
Cabaletta Bio
Cabaletta Bio has adapted clinically-validated and FDA-approved CAR T cell technology to target B cell-mediated autoimmune diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$310MKey Investors
5AM Ventures
2025-06-11Post Ipo Equity· $100M
2023-05-17Post Ipo Equity· $87M
2022-12-08Post Ipo Equity· $35M
Leadership Team
Samik Basu
Chief Scientific Officer
Steve Gavel
Chief Commercial Officer
Recent News
GlobeNewswire
2026-01-12
2025-12-11
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