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 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
Reporting to the Vice President, Clinical Operations you will be tasked with keeping a growing program of early phase trials within timeline, budget, and compliance. This role will also have resource management, mentorship, and oversight responsibilities. An ideal candidate will be an effective problem solver, with the willingness to contribute to both the overall strategy of the clinical operations function as well as possess a "roll up your sleeves" type of an attitude.
- Plan operational delivery and direction of clinical studies across designated programs, oversee cross-functional alignment, budget, and timeline from protocol generation through completion of clinical study reports
- Guide the development of clinical operations documents and procedures required to conduct clinical studies
- Serve as delegate for the Head of Clinical Operations at meetings for designated programs
- Lead and support key Clinical Operation functional excellence activities, including project management processes and Good Clinical Practices (GCPs)
- Manage clinical studies’ vendor timelines, through designated contracts or service agreements
- Identify and interpret risks, program or resource gaps and implement mitigation strategies or corrective actions to address them
- Develop and track KPIs with CROs and other vendors
- Build relationships with vendors and all program and study key stakeholders to oversee clinical study progress, develop solutions to accelerate enrollment, and expand to additional sites, as necessary
- Contribute to development of key regulatory documents such as INDs and CTAs
- Contribute to all elements of data management activities, to support timely database builds, process flows and electronic data capture from multiple clinical sites, data management and closeout for each respective study and ensure site compliance and data quality
- Ensure compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities
- May require management of day-to-day study operations as needed.
- Experience with early stage (Phase I / II) clinical studies
- Experience conducting gene or cell therapy clinical trials
- Bachelor’s degree in the Life Sciences or equivalent healthcare degree with 8+ years’ industry experience in Study Management or Clinical Program Management working within a complex cross functional clinical trial execution environment
- Demonstrated experience in building and maintaining strong relationships with clinical trial sites, vendors, and associate personnel, with a strong customer-focused mindset
- Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
- Detailed understanding of all aspects of clinical protocol design, implementation, BLA/NDA submissions and overall drug development
- Proven track record demonstrating excellent clinical project management and project execution skills including clinical supply logistics and sample management
- Outstanding written communication skills including writing technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail
- Strong team orientation and passion for continuous self-development.
- Experience in industry or in a startup industrial setting is preferred.
- Experience successfully managing other clinical operations personnel
- Ability to think critically and creatively with a strong attention to detail
- Self-motivated and able to work autonomously
- Produces top-quality work with little oversight
- Demonstrated ability to juggle multiple priorities in a fast-paced environment
- Able to build strong relationships and collaborate effectively with colleagues
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.