Cabaletta Bio (NASDAQ: CABA) is focused on the discovery and development of T cell therapies for B cell-mediated autoimmune diseases. Our proprietary technology utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to precisely bind and destroy only specific autoantibody-expressing B cells while sparing normal antibody-expressing B cells, which are essential for human health. Cabaletta’s Approach for selective B cell Ablation platform, called our CABA™ platform, has applicability across more than two dozen B cell-mediated autoimmune diseases that we have identified, reviewed and prioritized. CAAR T technology is based on the revolutionary Chimeric Antigen Receptor (CAR) T cell technology developed at the University of Pennsylvania that resulted in one of the first commercially-available CAR T cell products for the treatment of B cell malignancies. Cabaletta has an exclusive global licensing agreement and multiple sponsored research agreements with the University of Pennsylvania to develop CAAR T technology to treat B cell-mediated autoimmune diseases.
The Company’s lead product candidate, DSG3-CAART, received IND clearance from the FDA in September 2019. DSG3-CAART is designed to be a potential treatment for patients with mucosal pemphigus vulgaris (mPV), which is a rare autoimmune blistering disorder that causes painful blisters and sores on mucous membranes leading to severe and sometimes debilitating and life-altering effects. The Company is expected to begin clinical trials for the lead compound for mPV in 2020. Cabaletta Bio is also pursuing a second product candidate, MuSK-CAART, designed to treat patients with MuSK-positive Myasthenia Gravis.
Uniquely Differentiated. Rapid. Elegant.
At Cabaletta, we are driven by the shared mission of developing a new type of therapy, where patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that success in the Cabaletta mission lies in the hands of individuals across every aspect of the company. To nurture this, we make an active commitment to the well-being and continuous growth of each person who joins our team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew
About the Position
Reporting to the VP, Clinical Operations, we are seeking an experienced and motivated Clinical Trial Associate. The Clinical Trial Associate will be responsible for providing logistical support to one or more study teams through all phases of clinical study management (Planning, Start-up, Conduct, and Close-out) in accordance with appropriate quality standards including ICH/GCP and applicable regulations. Responsibilities include, but are not limited to, collecting and reviewing essential regulatory documents, maintaining the trial master file, study status tracking, and scheduling and support of various study team and clinical department meetings.
Responsibilities will include:
- Support study feasibility activities and perform database/web searches for sites as needed.
- Work closely with Clinical Research Associates to ensure all study related regulatory and financial documents are collected and reviewed in support of study activation.
- Organize and maintain project working files and study electronic trial master files, and track and file critical documents. Report discrepancies to the appropriate clinical team member in a timely manner.
- Track and assist with processing vendor payments. Follow up on any issues as required.
- Maintain central database of contact information for clinical sites, CROs, vendors and CRAs.
- Collect and track site activation and patient enrollment and visit schedule information, and update study management reports as necessary.
- Maintain central tracking of site monitoring visits and trip report completion
- Generate reports in various applications to assist in oversight of site monitoring and clinical data review.
- Assist with the planning and support of study and project team including scheduling, preparation and distribution meeting agendas, and preparing minutes. Actively participate in team meetings.
- Communicate with central IRBs and outside vendors to facilitate IRB submissions and provide information and/or resolution to specific requests/issues.
- Support and correspond with sites to identify site specific needs (e.g. order and track trial related supplies, respond to requests for documentation and information).
- Manage and coordinate travel requirements for group, consultants, and partners as needed.
- Bachelor’s Degree
- 2-4 years relevant experience in pharmaceutical/biotech industry or CRO
- Experience supporting clinical trials and review of essential regulatory documents
- Basic knowledge of drug development and FDA GCP/ICH guidelines
- Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
- Experience using electronic data capture (EDC), electronic trial master file (eTMF) and clinical trial management (CTMS) systems is strongly preferred
- Strong team orientation and passion for continuous self-development.
Our name – Cabaletta – is derived from the operatic term for the second part of an aria that is designed to highlight the technical expertise of the lead singer. While our company is not the first to develop chimeric T cells as therapies, we are the first to develop them in a way that leverages T cells to specifically eliminate only B cells that cause disease, while sparing healthy B cells. Utilizing the backbone of this core technology, we expect to advance our portfolio with a rapid and repetitive rhythm, similar to the rhythm that is typical of a cabaletta.
For more information, please visit https://www.cabalettabio.com/ or email email@example.com directly to submit an application. Please include your CV along with the title of the position you are applying for.
Our most important asset is our people and we offer competitive benefits including a selection of medical, dental, vision plans, 401K match, transportation stipends, 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.