Associate Director - Program Management – Quality & Compliance Programs

Cabaletta Bio•Philadelphia, PA

14d•Hybrid

About The Position

Cabaletta Bio 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 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: (Hybrid/Philadelphia) Reporting into the PMO, the Associate Director – Program Management, Quality & Compliance will support the strategic planning, coordination, and execution of all Quality activities across all stages of product development and commercialization. This role operates within the Quality & Compliance department with close collaboration with the enterprise PMO team and cross-functional teams beyond Quality & Compliance. The Associate Director PM – Quality & Compliance must have extensive experience in supporting Quality programs, excellent leadership skills, and an understanding of the interdependent relationships between different sectors of Quality with other departments. The candidate must manage relationships and project schedules across the overall Quality programs to successfully deliver on their responsibilities. The individual is responsible for ensuring all Quality and Compliance activities are robustly mapped out and continuously updated, with risk registers driving contemplation of contingency scenarios. Working as an integrated member of the Quality & Compliance LT, the Associate Director PM will ensure that the program plans, supporting an autologous cell therapy product, are aligned with the overall asset and program timelines, corporate objectives and strategic initiatives. The ideal candidate will have 8+ years experience in program management field in a biotech, cell and gene therapy manufacturing, excellent PM practices, advanced strategic planning skills and high proficiency in SmartSheet.

Requirements

Experience in pharmaceutical or biotechnology industries is required.
8+ years of experience in technical operations, specific project/program management experience required, C>, CAR-T or similar industry preferred.
Direct experience supporting regulatory Health Authority Inspections in a GxP-regulated environment is required.
Proficiency in MS Office (MS Outlook, PowerPoint, Excel, and Word); familiarity with project management tools is required.
Strong understanding of PM Best Practices, operating in a PMO and how to scale processes in a growing corporate environment is required.
Extensive experience in utilization of Smartsheet including creation, maintenance, and reporting of timelines, Gantt charts, dashboards, and reports.
Excellent external facing representation and experience in managing vendor relationships and contracts.
Strong verbal and written communication skills.
Outstanding attention to detail with the ability to manage multiple tasks and priorities.
Ability to work both independently and collaboratively with cross-functional teams.
Thrives in a dynamic, fast-paced, timeline-based environment.
Strong customer service focus as part of Cabaletta’s PM culture.

Nice To Haves

Advanced degree in Life Sciences is preferred.
Certification in project management (e.g., PMP, CAPM) is preferred.
Experience with both early- and late-stage clinical programs is an advantage.

Responsibilities

Partner with various Program Leads of Quality programs to effectively manage the projects and programs.
Schedule and lead team meetings including developing agendas, publishing meeting minutes and decision logs, and tracking action items to completion.
Initiate and maintain cross-functional collaboration and communication, as needed, to drive project progress and team alignment.
Prepare and present slide decks, project reporting and updates to senior management and other key stakeholders to inform and drive decision making.
Work with Quality & Compliance Leadership Team to provide scenario planning and project reporting for all Quality & Compliance project management activities, aligning them with company goals and regulatory requirements, including the development and maintenance of charters, dashboards, trackers, schedules and other PM documentation.
Routinely perform project planning and due diligence including development of scope, timeline, budget, and resource plan to Quality-focused and Enterprise project portfolio.
Extensively support ongoing program management initiatives for the enterprise PMO by utilization and/or creation of project management tools and templates across the company contributing to a continuous improvement culture.
Work extensively with the lead Asset PM to support our cross-functional Product Development Team Program (PDT) and the CABA-201 clinical program.
Work closely with Clinical Teams, Regulatory Affairs, Technical Development and Supply Chain to support the preparation and submission of regulatory filings, including INDs, and BLAs.
Work with all appropriate stakeholders to identify potential project risks, maintain risk registers, conduct risk assessments and develop mitigation strategies to address them proactively.
Be a strategic partner with Finance and Legal teams to quickly resolve issues, and facilitate on-time, on budget delivery of project milestones.
Work across time zones as necessary.
Travel 10-15% may be required.
Other duties as assigned.
Utilize SmartSheet for project planning, tracking, and reporting both within a singular project and across multiple projects/programs creating one unified portfolio summary/report
Create, maintain, and publish SmartSheet dashboards and reports for project status updates.
Work with the PMO team to ensure that all department timelines and risk trackers integrate within the overall corporate portfolio and integrated roadmaps.
As SmartSheet Super User, train and support team members on SmartSheet use, management, and reporting as well as other functionalities, as needed.