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 / Director, Clinical Scientist will collaborate with cross-functional teams (Clinical, Regulatory, Medical Writing, Translational Sciences, CMC, etc.) on writing clinical study synopses and protocols, Investigator Brochures, and clinical study reports; participating in emerging clinical trial data evaluation and interpretation; ensuring that assigned studies are conducted according to GCPs and Cabaletta’s SOPs; interacting with health authorities such as the FDA related to clinical trials, reviewing SAPs and TLF shells; conducting literature searches; overseeing the review of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov (clinical trial registry and results database) and assisting in preparation of IND/ BLA filing and accelerated/pediatric programs packages. The span of responsibilities is broad and will support several clinical programs depending on their size and complexity. The Clinical Scientist will liaise with various vendors and study investigators at participating sites.

 

Responsibilities:

• Collaborate with the Medical Director or serve as Clinical Lead in clinical science aspects of the assigned Cell Therapy program.
• Collaborate with the Medical Director for clinical input to the clinical development plan (CDP) at all stages of the program.
• Leads (or supports) development of recommendations on further development strategies to internal committees.
• Participate in the cross-functional clinical trial team for assigned studies.
• Participate in review of clinical and scientific data and developing product knowledge to understand and communicate the relevant information.
• Participate in development, maintenance, and review of clinical study documents (e.g., protocols and protocol amendment(s), informed consent documents, case report forms) and other relevant strategic documents.
• Support activities related to the start-up and execution of new clinical trials.
• Contribute relevant clinical sections to documents such as the IB, DSUR, CSRs and regulatory documents such as INDs, CTAs, accelerated program, RMAT designations, pediatric study plans, BLAs, and MAAs.
• Be responsible for clinical data review and drafting reports and presentations on the various findings of the clinical research, including abstracts, posters, publications.
• Provide support with the activities related to the execution, monitoring, and reporting of clinical trials.
• Provide scientific/medical mentorship (or coordinates) to the study team, including the CRO team.
• Perform regular review of clinical data to ensure that the study is conducted in accordance with the protocol, safety procedures are followed, and efficiency is maintained.
• Assist with safety review procedures: tracking of safety events, review of new SAEs, and composing/editing adverse event narratives.
• Assist with managing vendor activities as needed.
• In collaboration with the Medical Director, identify clinical sites that will participate in trials. Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies.
• Attend Site Initiation Visits to present the study design and key aspects of the protocol, as needed.
• Lead the compilation and interpretation of the data for safety review committees, collaborating closely with the Medical Director.

 

Qualifications:

• Bachelor of Science degree from an accredited educational institution.
• Master's degree or PhD, PharmD/RN or the equivalent degree preferred.
• Minimum 7 years of experience in clinical drug development within a pharmaceutical/biotech or academic environment.
• Experience in the biotech industry or in a startup industry setting is preferred.
• Strong knowledge of ICH, GCP, and other relevant regulatory guidelines.
• Solid understanding of T-cell biology and cell & gene therapy.
• Prior experience in cell therapy in pharma/biotech is a plus.
• Experience in writing clinical protocols and performing and summarizing relevant literature reviews.
• Strong communication and interpersonal skills.
• Engaged, hands-on, and goal-oriented mentality in a highly dynamic work environment.
• Ability to flexibly contribute simultaneously to multiple facets of drug development.
• Demonstrated ability 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.
• Thrives in a fast-paced small company environment and able to adjust priorities and workload based upon changing needs.
• 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.