Philadelphia, PA

 

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs 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 manage all data management (DM) activities from start-up through long term follow up and archival, overseeing high quality databases for analysis and potential regulatory submissions.

 

Responsibilities:

• Assist Data reconciliation of electronic data transfers from vendor to Sponsor.
•  Enthusiastic and knowledgeable communication with database (DB) vendors on consistent basis to address Clinical team requests and/or eCRF development activities.
• Provide Clinical Data Management support to the Clinical team and other cross functional departments as needed.
• Develop CRF, electronic and/or paper.
• Participate in the review of Clinical research documents (e.g. Protocols, Case Report Forms).
• Develop clinical trial data specifications, including CRF completion guidelines, user requirements, edit checks and rules, query logic and data validations.
• Participate in UAT of eCRF build and validation documents, including but not limited to edit check document, issue log, and UAT summary report.
• Assist with TLF Development for DSMB/IDMC and endpoint adjudication committees.
• Participate in the preparation and presentation of data, when applicable.
• Ensure data compliance by following the established guidelines of national and international regulatory authorities.
• Assist in the review of routine/interim/final data listings prior to release to other groups or inclusion in regulatory submissions.
• Assist in the gathering of EDC design requirements from stakeholders and  to address the needs of sites (e.g., investigator, study coordinator, study monitor) .
• Provide input and support on data and submission standards (e.g., SDTM,ADaM) to project teams to ensure high quality and timely  deliverables that meet industry standards and regulatory requirements.
• Support the identification, review, evaluation, and implementation of new technologies related to clinical data  and to reduce site burden.
• Participate in data standards process improvement working groups.

 

Qualifications:

• Bachelor’s degree in a science related field.
• 8+ years data management and drug development in Clinical Data Management function.
• 5+ years managing vendor relationships.
• Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• BLA/NDA/CTD Experience preferred.
• Experience of data management best practices, standards, library development and maintenance.
• Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Experience of broad drug development process with expertise in the interfaces with the data management function.
• Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Working knowledge of Clinical database applications such as EDC and CTMS.
• Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
• Ensure adherence to functional budget, and provide updates to manager regarding additional, potential spend or cost savings.
• Knowledge of CDISC standards.
• Experience performing CRF Design activities in a clinical research environment.
• Outstanding verbal, written, organizational, interpersonal, and team skills.
• Create and implement solutions based on direct experience.

 

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.