Director, Clinical Scientist

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

Remote

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com

and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®

Position Description

This role can be remote or based out of our Philadelphia, PA headquarters.

The Director, Clinical Scientist plays a key role in supporting the clinical development of the company’s CAR-T cell therapy programs in autoimmune diseases. This individual contributes to the scientific and clinical integrity of trials from early proof-of-concept through late-stage pivotal studies, working closely with Clinical Operations, Translational Medicine, Regulatory, and Biostatistics to help ensure high-quality data and alignment toward a successful BLA submission. They serve as an important scientific link between discovery and clinical execution, bringing expertise in autoimmune diseases, cell therapy, and clinical trial design to support the advancement of transformative therapies for patients.

Key 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

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 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.

Our name — Cabaletta — is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long‑term immunosuppression.

For more information, please visit https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.