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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, hybrid or based in our Philadelphia, PA headquarters.

Reporting to the Senior Director, GCP Quality & Compliance, the TMF Manager is a key leader within the Quality and Compliance organization. This role has overall accountability for the strategic oversight, lifecycle management, and inspection readiness of the Trial Master File (TMF) across all clinical trials. The TMF Manager ensures trial documentation quality, completeness, consistency, and timeliness in alignment with ICH GCP, regulatory authority expectations, company SOPs, and the TMF Reference Model.

The TMF Manager serves as a subject matter expert (SME) for TMF and eTMF processes, partners cross-functionally with Clinical Operations, Clinical Development, Regulatory, and external vendors, and provides leadership, guidance, and escalation management for TMF-related risks and issues across programs.

Responsibilities:

TMF Oversight and Governance

• Provide strategic oversight of TMF management across all studies, ensuring inspection readiness at all times
• Establish and maintain studylevel TMF plans, master lists, and expected document lists in alignment with the TMF Reference Model
• Ensure adherence to ICH/GCP guidelines, regulatory requirements, and company policies related to TMF completeness and accuracy
• Oversee study startup, maintenance, closeout, and archival readiness for all assigned trials

Quality and Compliance

• Lead and oversee riskbased TMF quality and completeness reviews using metrics, dashboards, and reports
• Identify, trend, and escalate TMF quality issues, risks, and noncompliance to management with proposed mitigation strategies
• Ensure timely resolution of overdue, missing, or incorrect TMF documents
• Support internal audits, vendor audits, inspections, and health authority requests related to TMF

eTMF System and Process Management

• Act as TMF/eTMF Subject Matter Expert across therapeutic areas and research phases
• Partner with system owners and vendors to support eTMF enhancements, implementations, and change initiatives
• Oversee complex TMF data extracts, exports, health authority requests, and divestiture support
• Ensure proper archival, longterm storage, and retention of clinical trial documentation

Leadership and CrossFunctional Collaboration

• Provide functional guidance, training, and mentoring to TMF contributors and study teams
• Partner with CROs, Clinical Operations, study teams, and vendors to ensure clear TMF roles, responsibilities, and expectations and to promote TMF best practices
• Serve as the primary TMF point of contact for CROs, supporting oversight, issue resolution, and escalation management
• Support change management initiatives to drive TMF process efficiency and inspection readiness
• Leverage strong influencing and communication skills to align stakeholders and resolve issues

Qualifications:

• Bachelor's degree in a scientific or related discipline required.
• Minimum of 5 years of TMF experience, including study start-up, maintenance, closeout, and quality/completeness review.
• Experience in clinical trial-related roles (e.g., Clinical Operations, Project Management); demonstrated ability to manage multiple projects in a fast-paced environment and meet tight timelines.
• Strong knowledge and application of ALCOA+ principles, Good Clinical Practice (GCP), Good Documentation Practices (GDP), and ICH E6(R2) guidelines.
• Subject matter expertise in clinical trial documentation, TMF Reference Model, and associated processes and terminology.
• Knowledge of core, country, and site-level essential documents.
• Proficiency in eTMF systems and Microsoft Office tools.
• Strong critical thinking skills, with the ability to analyze and evaluate information to support quality review and decision-making.
• Excellent verbal and written communication and interpersonal skills.
• Collaborative team orientation with a commitment to continuous learning and development.
• Experience in industry, preferably within a startup 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