Cabaletta Bio Inc.

Director, Pharmacovigilance 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 based out of our Philadelphia, PA headquarters, hybrid, or remote. Reporting into the VP, Clinical Development, the Director, Pharmacovigilance will lead and execute global safety and pharmacovigilance activities across clinical-stage CAR-T programs in autoimmune diseases. This role is responsible for ensuring high-quality safety data collection, analysis, and reporting in compliance with global regulatory requirements, while partnering cross-functionally to support clinical development and future regulatory submissions. This is a highly collaborative and hands-on role, working closely with Medical Directors, Clinical Scientists, Clinical Operations, Regulatory, and Medical Affairs to proactively identify, evaluate, and communicate safety signals. The ideal candidate thrives in a fast-paced, evolving environment and is equally comfortable setting strategy and diving into execution. Key Responsibilities: Safety Strategy & Oversight - Lead pharmacovigilance strategy across clinical programs, ensuring alignment with overall clinical development plans. - Serve as the safety lead on study teams, providing medical and scientific input on safety data interpretation and risk management. - Contribute to the development and maintenance of safety-related documents, including DSURs, IBs, protocols, and safety sections of regulatory submissions (e.g., INDs/BLAs). Case Management & Signal Detection - Oversee case processing activities, including SAE review, medical assessment, and timely reporting in compliance with global regulations. - Lead signal detection, evaluation, and risk assessment activities, including aggregate data review and benefit-risk evaluation. - Ensure appropriate escalation and communication of safety signals to internal stakeholders and governance committees. Regulatory Compliance & Inspection Readiness - Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines. - Support health authority interactions related to safety and pharmacovigilance. - Contribute to inspection readiness activities and support audits and inspections as needed. Cross-Functional Collaboration - Partner closely with Clinical Development, Clinical Operations, Regulatory, and Medical Affairs to ensure integrated safety oversight across programs. - Provide safety input into clinical trial design, study conduct, and data review processes. - Collaborate with external vendors (e.g., CROs, safety databases) to ensure high-quality PV operations. Operational Leadership - Establish and refine pharmacovigilance processes, systems, and infrastructure to support a growing clinical pipeline. - Oversee PV vendors and ensure performance, quality, and compliance. - Contribute to building scalable PV capabilities in preparation for late-stage development and potential commercialization. Qualifications: - Advanced degree (MD, PharmD, PhD, or equivalent) in a relevant scientific or medical discipline preferred. - Minimum of 8–10 years of pharmacovigilance/safety experience in biotech or pharmaceutical industry, including clinical-stage programs. - Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH). - Experience supporting clinical trials, including safety monitoring, signal detection, and aggregate reporting (e.g., DSURs). - Prior experience in cell and gene therapy, immunology, or related therapeutic areas strongly preferred. - Demonstrated ability to work cross-functionally and influence without authority in a matrixed environment. - Proven ability to operate both strategically and hands-on in a fast-paced, resource-constrained setting. - Experience working in or with early-stage or growth-stage biotech companies preferred. - Excellent analytical, communication, and problem-solving skills. - Strong attention to detail and commitment to quality and patient safety. 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

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. 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

Associate Director, Medical Affairs (Scientific Communications / Publications) 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 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 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 (East Coast hours) or based out of our Philadelphia, PA headquarters. We are seeking a detail-oriented and proactive Associate Director, Medical Affairs to support our Clinical/Medical/Regulatory (CMR) team in the efficient planning, preparation, and data dissemination at conferences and in journal publications. Reporting to the Senior Director, Medical Affairs, the ideal candidate will have a strong background in scientific writing, scientific conference management, publication planning, and project management within the biotechnology or pharmaceutical sectors. Responsibilities: - Manage the end-to-end process of publication planning, ensuring adherence to timelines and compliance with industry standards. - Collaborate with cross-functional teams, including Clinical Development, Translational Medicine, Computational Biology, Regulatory Affairs, and external authors/key opinion leaders, and vendors, to facilitate the development of manuscripts, abstracts, posters, and presentations. - Manage the operational execution and day-to-day budget for external medical writing and communications agencies that support content and publication deliverables. - Lead the preparation of journal manuscripts and abstracts and presentations for medical conferences, ensuring compliance with conference guidelines and requirements. - Advise teams regarding compliance with medical publications as defined in journal and congress guidelines. - Coordinate internal review processes and facilitate approval workflows for publications in collaboration with Legal, Compliance, and Medical teams. - Train internal teams on publications software and workflows. - Assist in the preparation of scientific content for medical conferences and other scientific forums. - Maintain awareness of industry trends and regulatory guidelines related to publication practices in the biopharmaceutical industry. - Develop and execute comprehensive scientific engagement strategies and congress plans (i.e. manage relationships with conference organizers, lead internal pre/post congress meetings, organize onsite HCP meetings, etc.). - Conduct literature searches and maintain databases of scientific publications relevant to cell therapy and related therapeutic areas. - Assist in the development and execution of medical affairs activities including advisory boards, internal trainings, patient advocacy group engagements, etc. - Ability to travel up to 25% to attend conferences and meetings. - Partner with cross functional teams to create integrated evidence generations plans. Qualifications: - Master’s degree in Health Care, Life Sciences, Biomedical Sciences, or a related field. Terminal degree in Life Sciences or healthcare (PharmD, PhD, MD, etc.) preferred. - >3 years of experience in medical affairs, scientific communications, or publication planning within the biotechnology or pharmaceutical industry. - Therapy area experience in rheumatology, neurology, immunology, and/or cell therapy - Experience working with publications management software/vendors (such as iEnvision, PubStrat, PubPro) - Experience managing a publications or asset/project budget including overseeing external vendors - Strong scientific writing skills with the ability to translate complex scientific data into clear and concise publications, including ability to analyze and interpret clinical trial data. - Knowledge of publication guidelines (e.g., ICMJE, GPP2022) and industry best practices. - Excellent organizational skills with the ability to manage multiple projects simultaneously and meet deadlines. - Proficiency in Microsoft 365 (Word, Excel, PowerPoint, OneNote) - Preferred: Certified Medical Publication Professional (CMPP) and ISMPP active member Personal Attributes: - Detail-oriented and meticulous in maintaining data integrity and publication records. - Strong interpersonal and communication skills to collaborate effectively with internal stakeholders and external authors. - Proactive and self-motivated with a strong sense of accountability and ownership. - Ability to thrive in a dynamic and fast-paced environment while maintaining high standards of quality and compliance. 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

Vice President, Biostatistics 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 based out of our Philadelphia, PA headquarters, hybrid, or remote (strong preference for candidates based in the Northeast). The Vice President, Biostatistics is a key enterprise leader responsible for setting the strategic direction, vision, and executional rigor of the company’s biostatistics and data management capabilities. Reporting to the VP, Clinical Development, this leader will serve as the principal statistical authority across the organization—guiding program strategy, influencing portfolio decisions, and ensuring statistical excellence from early development through registration-stage programs. This role requires deep expertise in statistical methodologies, strong scientific judgment, and the ability to anticipate what is required to advance complex clinical programs in a dynamic environment. The ideal candidate will balance scientific rigor with operational pragmatism, provide leadership across functions, and communicate effectively with executive leaders, scientific teams, regulators, and external partners. As a senior leader in a fast-paced, growing company, the VP will also be instrumental in building organizational capability, advancing operational excellence, and fostering a high-performing, collaborative culture aligned with our values. Key Responsibilities: - Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture. - Recruit, mentor, and inspire the team to ensure organizational capability scales with the company’s clinical portfolio. - Serve as a strategic advisor to executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making. - Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection to optimize probability of technical and regulatory success. - Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings. - Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning. - Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies. - Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation. - Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making. - Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials. Late stage development experience is strongly preferred. - Represent the company in regulatory meetings as needed and ensure alignment with global regulatory standards and evolving guidance. - Oversee CROs, data vendors, and technology platforms to ensure high-quality deliverables, on-time execution, and compliance with regulatory and industry standards. - Champion modern data management and statistical computing practices, ensuring infrastructure supports scale, audit readiness, and efficiency. - Stay abreast of emerging statistical methodologies, regulatory trends, and industry best practices to ensure the organization remains at the forefront of scientific and statistical innovation. Qualifications: - PhD or Master’s degree in Biostatistics, Statistics, or related field. - 10+ years of relevant experience in biotech/pharmaceutical R&D, including leadership of statistical strategy for early and late-stage clinical programs. Leadership & Strategic Impact - At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups. - Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions. - Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams. - Strong track record of contributing to late-stage development/regulatory submissions with BLA experience strongly preferred. - Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness. - Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences. - Experience managing departmental budgets, vendor relationships, and technical infrastructure. - Highly collaborative, with strong interpersonal skills and the ability to build trust across teams. - Strategic thinker with strong scientific rigor and operational pragmatism. - Thrives in a fast-paced, evolving environment; able to manage multiple priorities with clarity and focus. - Demonstrates integrity, accountability, and a commitment to continuous learning and team development. - Comfortable with hands-on leadership in a small-company 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

Senior In-House Clinical Research Associate 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 Senior In-House Clinical Research Associate (CRA) supports the planning, execution, and oversight of Cabaletta Bio’s clinical trials, serving as a key operational and external-facing partner to clinical sites, CROs, and vendors. This role works cross-functionally with Clinical Project Management, Clinical Trial Management, and the broader Clinical Operations team to ensure high-quality trial conduct, strong site and vendor relationships, and inspection-ready documentation throughout the study lifecycle. This role will play a key part in bring complex studies forward in a fast-paced, mission-driven environment. Key Responsibilities: - Provide monitoring oversight by reviewing monitoring reports and escalate any trends with respect to data quality or study conduct to the appropriate CTM, Clinical Operations. - Perform clinical research site activities, such as onsite or remote co-monitoring, training, motivational, and sponsor oversight visits, as needed. - Support the oversight of activities of CRO and study vendors to ensure compliance with the study protocol and on-time achievement of overall clinical objectives and deliverables. - Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, study plans and CRFs. Contribute to study start-up activities including site selection. - Support the Clinical Operations team and cross-functional representatives as required in relationship management tasks (e.g., study logistics, patient enrollment, safety, data management, etc.) to accurately coordinate clinical study activities. - Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies. - Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of study activities. - Identify and resolve study-related issues and deviations. - Communicate with study sites and investigators. - Provide support to study sites, including training and troubleshooting. - Support various administrative tasks for the Clinical Operations team including scheduling meetings and taking minutes. - Perform other duties and assignments as required for the overall success of the projects. Qualifications: - A bachelor's or master's degree in a relevant field, such as life sciences, nursing, or pharmacy. - At least 2-3 years of experience in clinical research, preferably in a CRA or related role. - Experience with all aspects of trial and site startup and vendor selection and management, study management, and monitoring. - Strong knowledge of clinical trial conduct, GCP, FDA regulations, and ICH guidelines. - Excellent written and verbal communication skills to effectively communicate with study sites, investigators, and internal study team members. - Strong organizational skills to manage multiple tasks and priorities simultaneously. - Strong attention to detail to ensure accurate and complete data collection and documentation. - Proficiency in Microsoft Office applications and experience working with electronic data capture systems (EDC). - Ability to build positive relationships with study sites and investigators. - Flexibility to adapt to changing project needs and timelines. - Strong team orientation and passion for continuous self-development. - Experience in a startup setting is preferred. - Ability to travel up to 10%, if needed. 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

Vice President, Regulatory Affairs 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. Reporting to the Chief Medical Officer, the Vice President of Regulatory Affairs is responsible for driving success and will lead the global regulatory strategy and execution for an advanced cell therapy product development program. This role is responsible for ensuring compliance with all applicable regulations, guiding interactions with health authorities (FDA, EMA, and other global agencies), and driving successful regulatory submissions and approvals. The VP will serve as a key member of the product development team, influencing development strategy and lifecycle management for autologous cell therapy products. Key Responsibilities: Strategic Leadership - Develop and implement global regulatory strategies for cell therapy programs across clinical development, manufacturing, and commercialization. - Serve as the primary regulatory advisor to executive leadership, ensuring alignment with corporate objectives and regulatory requirements. - Anticipate and interpret evolving regulatory trends in cell and gene therapy, including FDA CBER guidance and EMA ATMP frameworks. - Assess and communicate potential regulatory risks and propose mitigation plans. Regulatory Submissions & Compliance - Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development. - Oversee content preparation and submission of INDs, CTAS, and BLAs/MAAs, and other relevant submissions to regulatory agencies. - Lead strategy for global expedited pathways (e.g. RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (US and EU), where applicable. - Ensure compliance of programs and submission documentation for adherence to GxP, ICH, and regional regulatory requirements throughout development and manufacturing. Regulatory Interactions - Build and maintain strong relationships with FDA CBER and other regulatory agencies and represent the company in key regulatory meetings and negotiations. - Ensure timely and high-quality responses to health authority inquiries, including pre-BLA meetings, Type B/C/D meetings, and scientific advice. Team Leadership - Build and manage a high-performing regulatory affairs, operations, writing, and CMC regulatory with expertise in cell and gene therapy. - Foster a culture of compliance, innovation, and continuous improvement. - Coach team members on technical skills and leadership behaviors. Qualifications: - Advanced degree in life sciences, pharmacy, or related field (PhD, PharmD, or equivalent preferred). - 15+ years of regulatory affairs experience in biopharmaceuticals from pre-clinical to commercialization, with at least 8 years in leadership roles. - Experience in cell and gene therapy field is preferred - Proven track record of successful IND and BLA submissions (prior BLA experience required) - Deep knowledge of FDA CBER regulations, EMA ATMP guidelines, GxPs, and global regulatory frameworks. - Strong leadership, strategic thinking, and negotiation skills. - Excellent communication and stakeholder management abilities. - Strong team orientation and passion for continuous self-development 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

Director, Regulatory 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. We are seeking an experienced and highly motivated professional to join our team as a Director, Regulatory. This role will serve as the Regulatory Lead for our pivotal program leading to BLA. In this role, you will be responsible for developing and executing regulatory strategies to support the development and commercialization of our cell therapy products. You will work closely with cross-functional teams, regulatory agencies, and external partners to ensure compliance with regulatory requirements and successful product registration. If you are a passionate and experienced regulatory affairs professional with a strong knowledge of BLA requirements, we encourage you to apply for this position that will play a crucial role in advancing innovative cell therapies to benefit patients worldwide. Key Responsibilities: - Regulatory Strategy Development: - Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable. - Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development. - Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly. - Assess and communicate potential regulatory risks and propose mitigation plans. - Regulatory Submissions and Compliance: - Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA). - Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements. - Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products. - Regulatory Interactions: - Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication. - Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities - Coordinate and prepare responses to requests for information from regulatory agencies - Build and maintain positive relationships with regulatory authorities to facilitate successful regulatory approvals. Qualifications: - Bachelor's degree in life sciences or related field required (advanced degree preferred). - Minimum of 8 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred). - Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required). - Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions. - Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions. - Excellent communication, negotiation, and leadership skills - Strong team orientation and passion for continuous self-development 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

Sr. Medical Director, Clinical Development 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. East Coast candidates are preferred. Travel of 10-20% required. Cabaletta is seeking an experienced, highly motivated hands-on physician leader to serve as a Senior Medical Director, Clinical Development reporting to the VP, Clinical Development. This individual will provide the medical oversight and leadership of Cabaletta’s cell therapy programs in autoimmune diseases, including collaborating with the clinical operations, regulatory, translational research, manufacturing, and quality assurance functions; liaising with clinical investigators and site personnel; establishing and building relationships with key external experts; and interacting with Health Authority representatives, such as the FDA. The position requires a leader with significant experience working with CROs and vendors and interfacing with investigator sites to ensure operational efficiency and effective execution of trials within a complex, fast-paced environment. Key Responsibilities: - Provide medical leadership for various programs from first-in-human studies through registrational studies. Late-stage development experience is preferrable - Formulate study designs, lead protocol development, partner with internal cross-functional teams in study start-up activities, and collaborate with clinical investigators, key external experts, and Health Authorities - Participate in direct, hands-on involvement in all aspects of study conduct clinical activities, working with clinical operations, including data review, analysis, and reporting that conform to the ethical, safety, and quality standards of Cabaletta, GCP, and Health Authorities - Become an expert and remain current in the relevant therapeutic areas and in the field of cell and gene therapy through review of the scientific literature, interactions with key external experts, and attendance at relevant scientific meetings - Actively contribute during Health Authority interactions - Review available preclinical data that could inform the design of future clinical trials - Present at site evaluation and site initiation visits as applicable - In partnership with relevant cross-functional team members, actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents - Collaborating with cross-functional groups, formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data Qualifications: - M.D., M.D./Ph.D. degree or equivalent required - Board Certification, Board Eligibility, or clinical experience in the field of Rheumatology and/or Immunology highly desirable - 7+ years of experience in clinical research, including the design and execution of complex clinical trials, with a pharmaceutical or biotech company - Experience with or exposure to the development of adoptive cell therapies or biologic therapies is desirable - Experience with Health Authority interactions and submission of clinical regulatory documents is desirable - Strong written and verbal communication skills; ability to easily engage with investigators and key external experts; and ability to effectively present at conferences, advisory meetings, and other public for a - Engaged, hands-on, independent, and goal-oriented mentality; willingness to work in highly dynamic work environment - Ability to multi-task and willingness to flexibly contribute simultaneously to multiple facets of drug development; willingness to learn new therapeutic areas and technologies - Self-motivated, innovative, and critical thinker with strong commitment to follow up on action items; strong organizational, analytical, and problem-solving skills - Strong influencing skills and ability to create a clear sense of direction - Thrives in a fast-paced small company environment and able to adjust priorities and workload based upon changing needs - Comfortable with ambiguity and ability to define processes and procedures from scratch - Strong team orientation and passion for continuous self-development - Ability and willingness to travel as required 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