Associate Director, Clinical Data Management

Associate Director, Clinical Data Management (Remote)

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA™ platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or Chimeric Antigen Receptor T cells for Autoimmunity, is designed to potentially reset the immune system by causing transient B cell depletion with early academic clinical data suggesting the potential of this strategy to transform treatment in patients with SLE and the possibility of cures in rheumatoid arthritis, myositis, and systemic sclerosis, among others. Our lead product candidate using the CARTA strategy is CABA-201, 4-1BB-containing CD19-CAR T designed specifically to treat patients with autoimmune diseases with high unmet need, including systemic lupus erythematosus (SLE), myositis, systemic sclerosis, and generalized myasthenia gravis, and which uses a CD-19 binder that has an encouraging clinical tolerability profile. In addition to our CARTA candidate, CABA-201, we have a clinical-stage pipeline of Chimeric AutoAntibody Receptor T (CAART) cells targeted to the cells responsible for autoantibody-mediated autoimmune diseases.  Cabaletta Bio’s headquarters are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).

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®

About the Position:

The Associate Director, Clinical Data Management will serve as a senior Data Management Lead and strategic data management leader across assigned clinical studies. This role will provide end-to-end leadership from protocol review and study start-up through database lock, regulatory submission support, long-term follow-up, and archival, while ensuring high-quality, analysis-ready clinical data.

Responsibilities:

• Serve as senior Data Management Lead for assigned clinical studies across multiple phases, providing end-to-end leadership from protocol review through database lock, long-term follow-up, and archival.
• Review protocols and study strategies to ensure feasible, compliant, and effective data collection.
• Lead EDC, CRF, edit check, query logic, user requirements, and CRF completion guideline development.
• Oversee external data integrations, transfers, reconciliation, medical coding, and validation.
• Develop and maintain data management plans, database specifications, validation records, UAT documentation, and data review plans.
• Lead cross-functional data review and align stakeholders on quality, timelines, and risk mitigation.
• Oversee CROs and vendors, including selection, performance, quality, timelines, budgets, and change orders.
• Drive study and program milestones, proactively identifying risks and implementing solutions.
• Lead database testing, UAT, data cleaning, coding, reconciliation, database lock, and archival.
• Review data listings and support analyses, safety monitoring committees, endpoint adjudication, and submissions.
• Support regulatory submissions, health authority responses, inspection readiness, and audits.
• Ensure compliance with GCP, applicable FDA and ICH requirements, company procedures, industry standards, and applicable CDISC standards
• Contribute to data standards, SOPs, technology assessments, and continuous process improvement.
• Provide leadership, mentoring, and technical guidance to data management staff.
• Represent Clinical Data Management on cross-functional teams and communicate status, risks, and resource needs.

Qualifications:

• Bachelor's degree in life sciences, health sciences, or a related field.
• 10+ years of progressive clinical data management experience within the pharmaceutical, biotechnology, or clinical research industry.
• Demonstrated experience serving as a senior Data Management Lead and providing end-to-end leadership for global Phase I-IV clinical studies.
• Experience leading clinical data management strategy across multiple studies or development programs.
• Extensive experience overseeing CROs and external vendors, including vendor selection, performance, quality, timelines, budgets, and change orders.
• Demonstrated experience with EDC design and implementation, CRF design, edit checks, query logic, UAT, database validation, data review, and database lock.
• Experience managing external data integrations, data transfers, reconciliation activities, and medical coding processes.
• Working knowledge of MedDRA and WHO Drug dictionaries and coding practices.

• Experience supporting regulatory submissions, health authority responses, inspection readiness activities, and audits.
• Strong knowledge of GCP, FDA, ICH, and other regulatory requirements applicable to clinical data capture and management.
• Working knowledge of CDISC standards, including SDTM and ADaM, and experience collaborating with Biostatistics and Statistical Programming.
• Experience developing and maintaining clinical data management plans, database specifications, validation documentation, CRF completion guidelines, and other study documentation.
• Experience reviewing protocols, statistical analysis plans, CRFs, clinical study reports, and related clinical trial documents.
• Demonstrated ability to lead cross-functional data review, manage complex timelines and risks, and deliver high-quality, analysis-ready clinical data.
• Experience mentoring data management staff and contributing to SOP development, training, technology assessment, and process improvement.
• Outstanding written, verbal, organizational, interpersonal, problem-solving, and leadership skills.

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.

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