Philadelphia, PA

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 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

 

Reporting to the Director, Clinical Operations, we are seeking an experienced and motivated Sr. Manager, Clinical Operations.  The Sr. Manager, Clinical Operations will be a proactive, self-starter who is responsible for providing oversight and support to clinical operations vendors and teams in planning, execution, data management, and close-out of assigned clinical studies with a focus on quality and compliance. Additionally, this individual will be a key contributor to the clinical development planning and analysis and reporting of data for assigned programs, including applying his or her experience to the development of protocols, data management plans, statistical analysis plans, and safety reporting plans.  This individual will also contribute to Clinical Operations departmental continual process improvement initiatives related to study management, information and tracking systems, metrics, and the development of or enhancement of clinical operations SOPs.

 

Responsibilities:

• For assigned clinical studies, provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure. Manages all aspects proactively.
• Hands-on performance of activities not outsourced to vendors, as needed.
• Author study documents and plans such as ICF and study specific plans.
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate.
• Proactively identify risks and lead team members to mitigate risks in a timely fashion.
• Develop and maintain positive relationships both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators).
• Hands-on management of investigational sites and site monitors.
• Selection and management of multiple vendors.
• Perform and document study level Sponsor Oversight of outsourced clinical activities.
• Initiate and manage study-level timelines and enrollment, including communication to internal and external team members on deliverables.
• Perform periodic review of clinical data, quality metrics and study deviations.
• Review clinical monitoring reports to ensure timely completion and identification of issues.
• Manage laboratory samples to be sent to vendors in order to meet trial deliverables.
• Participate in testing of clinical trial systems/databases (i.e. UAT).
• Work with finance team to review and approve study and site budgets and budget templates.
• Provide critical thinking and escalation when issues arise during execution of clinical studies.
• Act as a liaison with other internal and external functional departments including quality assurance, data management, document management, regulatory, safety, translational research, clinical supply management, etc.
• Ensure high quality and compliance of work products to internal SOPs and external regulations to avoid unacceptable risk to the projects and functional area.
• Utilization of project management analytical methods to assess progress and risks for assigned studies.
• Oversee, lead and train study-specific team members as needed.
• Provide mentoring to assigned contract and permanent Clinical Operations staff (e.g., CRAs and CTAs).
• Support Clinical Operations departmental projects including continual process improvement initiatives and SOP development.
• Perform other duties as needed.

 

Qualifications:

 

• Bachelor’s degree and a minimum of 6 years clinical research experience.
• Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management.
• A minimum of 2+ years of Sponsor and Biotech start-up experience.
• Experience with early phase complex trials.
• Experience managing Contract Research Organizations and other external vendors (e.g., central laboratory vendor, etc.)
• Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management.
• General knowledge of other clinical trial functional areas and their respective deliverables including, regulatory affairs, data management, safety, medical monitoring, and medical writing.
• Working knowledge of GCP/ ICH regulatory guidelines.
• Strong attention to detail, good organizational and communication skills, ability to work independently and interact with senior management on a regular basis.
• Demonstrated leadership skills.
• Proficient with project management tools and analysis of metrics.
• Experience managing within a matrix management organization preferred.
• Management of global clinical trial strongly preferred.
• Cell/Gene therapy or oncology experience preferred.
• Ability to travel to clinical sites as needed (must have willingness to travel more frequently to study sites and vendors based on study demands). 
• Strong team orientation and passion for continuous self-development.
• Experience in industry or in a startup industrial setting is preferred.

 

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.