Director, Clinical Scientist

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 Bios headquarters and labs are located in Philadelphia PA. For more information please visit

and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta we are driven by the shared mission of developing cures where a patients 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 this way we are not only working to improve the lives of patients but of everyone involved. #CabalettaCrew.

Were 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 companys 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 experienceparticularly in CAR-T or T-cellbased modalitiesstrongly 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 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.

Cabaletta Bio Inc. does not accept unsolicited resumes from recruiters employment agencies or staffing firms. To conduct business with Cabaletta a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And if a resume or candidate is submitted by a recruiter an employment agency or a staffing firm without a fully executed MSA Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter agency and/or firm.

#LI-REMOTE