Sr. Director, Clinical Scientist

Philadelphia, PA

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 Sr. Director, Clinical Scientist plays a pivotal role in shaping the clinical development strategy for the company’s CAR-T cell therapy programs in autoimmune diseases. This leader drives the scientific and clinical integrity of trials from early proof-of-concept through late-stage pivotal studies, partnering closely with Clinical Operations, Translational Medicine, Regulatory, and Biostatistics to ensure high-quality data and alignment toward a successful BLA submission. They serve as the scientific bridge between discovery and clinical execution, providing deep expertise in autoimmune diseases, cell therapy, and clinical trial design to advance transformative therapies for patients.

Key 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.

Qualifications:

  • 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.

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.

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