Associate Director, Clinical Trial Lead, Clinical Operations

Associate Director, Clinical Trial Lead, Clinical Operations

Remote Role

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, the Associate Director, Clinical Trial Lead, 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.

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.

Key Responsibilities

• Lead the planning, execution, management, and delivery of assigned regional and global clinical trials from protocol development through study conduct, closeout, analysis, and reporting, ensuring alignment with development and regulatory strategies.
• Provide operational leadership and oversight for all clinical trial activities, including study startup, site activation, patient recruitment and enrollment, monitoring oversight, protocol deviation management, data review and cleaning, database lock readiness, and study closeout.
• Serve as the primary operational contact and liaison among internal cross-functional teams and external stakeholders, including CROs, clinical sites, vendors, regulatory affairs, quality assurance, safety, data management, medical writing, translational research, clinical supply, and document management.
• Oversee the selection, onboarding, management, and performance of CROs and vendors, ensuring delivery against study timelines, quality expectations, contractual obligations, and budget requirements.
• Build and maintain strong relationships with investigational sites, investigators, study coordinators, monitors, and vendor partners to support successful study execution.
• Develop, author, review, and approve key trial documents and operational plans, including protocols, protocol amendments, informed consent forms, study manuals, study plans, regulatory responses, and clinical study reports.
• Manage study budgets, forecasts, work orders, change orders, and financial performance while ensuring efficient use of resources.
• Apply project management methodologies and operational metrics to track study progress, identify risks, implement mitigation strategies, and facilitate informed decision-making.
• Drive innovative operational approaches and process improvements, including remote monitoring strategies, and optimized clinical supply management.
• Ensure compliance with ICH-GCP guidelines, applicable regulations, and company SOPs; proactively manage quality issues, CAPAs, inspection readiness activities, audit activities, and regulatory inspections.
• Perform operational activities that are retained in-house and not outsourced to vendors, as needed.
• Mentor, develop, and/or directly manage In-house CRAs, contingent workers, and other assigned personnel while fostering a collaborative, high-performance culture.
• Support departmental initiatives, continuous improvement efforts, and the development or revision of clinical operations procedures and SOPs.

Qualifications & Experience

• BA or BS degree in a scientific or healthcare-related discipline required.
• 8-10+ years of clinical research experience, including significant global clinical trial management experience within biotechnology or pharmaceutical company.
• Proven leadership of complex clinical studies, including oversight of budgets, timelines, vendors, resources, and risk management.
• Extensive experience managing CROs, external vendors, and cross-functional teams in a matrix environment.
• Strong knowledge of clinical trial operations, drug development, ICH-GCP, regulatory requirements, and inspection readiness.
• Experience across early and late-phase clinical development.
• Broad knowledge of managing within a matrix management with cross-functional clinical development disciplines, including regulatory affairs, data management, safety/pharmacovigilance, medical monitoring, biostatistics, clinical supply, and medical writing.
• Demonstrated ability to drive operational excellence, solve complex challenges, and influence stakeholders at all levels.
• Excellent leadership, project management, communication, and organizational skills.

• Cell/Gene therapy or oncology experience preferred.

• Willingness to travel up to 10% as required.