Manager, Clinical Operations, International (based in Europe)

Manager, Clinical Operations, International Europe (Germany or Switzerland) Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn. Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s 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® Position Description This role must be based in Germany or Switzerland. Candidates must be able to work remotely and travel up to 20-50%. Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. Reporting to the Executive Director, Clinical Operations, International, this role will be 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. They will be responsible for clinical oversight and will be a key contributor to the clinical development planning and analysis and reporting of data for assigned programs, including applying their experience to the development of protocols, data management plans, statistical analysis plans, and safety reporting plans. The Manager/Sr. Manager, Clinical Operations, International will also contribute to continual process improvement initiatives within the Clinical Operations department in the areas of study management, information and tracking systems, metrics, and the development/enhancement of clinical operations SOPs. Key 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. Perform hands-on activities not outsourced to vendors, as needed. Author study documents and plans such as ICF and study specific plans. Provide input and review of site training materials 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). Select and manage vendors. Perform and document study-level Sponsor Oversight of outsourced clinical activities. Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms. Initiate and manage study-level timelines and enrollment, including communication to internal and external team members on deliverables. Attend and present at study initiation visits (SIVs) and other site trainings/meetings. Serve as escalation point for site issues. Oversee monitoring activities, including report review. Support site supply management (e.g. lab kits, site tools, paper scales, thermometers, etc.) 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. Use 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 or advanced degree in life sciences or related field.Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience. Cell therapy experience preferred and/or focus complex therapies.Fluency in English; working proficiency in additional European languages a plusExperience with early phase, complex trials.Experience managing Contract Research Organizations and other external vendors (e.g., central laboratory vendor, etc.).Good understanding of European regulatory requirements (EMA, MHRA, etc.); Working knowledge of GCP/ ICH regulatory guidelines.Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management.CRA or CRA oversight experience in European sites preferred.Proven record of site and investigator/KOL interaction.General knowledge of other clinical trial functional areas and their respective deliverables including, regulatory affairs, data management, safety, medical monitoring, and medical writing.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.Strong problem-solving skills with a solution-focused approach.Proficient with project management tools and analysis of metrics.Ability to travel to clinical sites as needed.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.