Sr. Manager or Associate Director, Program Management – Clinical, Medical & Regulatory

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching 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.

About the role

Reporting into the PMO through the Sr. Director, Program Management, the Sr. Manager / Associate Director, Program Management – Clinical, Medical & Regulatory (CMR) leads the strategic planning, execution, and delivery of clinical programs uniting Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Regulatory functions and deliverables. This role operates as an embedded, matrixed member of the CMR organization while remaining part of the enterprise PMO, with close collaboration across cross-functional teams throughout the organization. Final level will be determined based on the candidate's experience and demonstrated scope of leadership.

The Sr. Manager / Associate Director ensures all clinical program activities are robustly planned, continuously maintained, and risk-managed with contingency scenarios, and that program plans supporting an autologous cell therapy product remain aligned with overall asset timelines, corporate objectives, and strategic initiatives.

Responsibilities

• Work with the CMR portfolio PM and lead Asset PM to align program planning and execution with corporate objectives and Product Development Team (PDT) strategy.
• Develop project scope, timelines, budgets, and resource plans across the clinical portfolio.
• Lead cross-functional study team and governance meetings, including agendas, decision logs, minutes, action-item tracking, collaboration, and team alignment.
• Partner with Clinical Operations, Clinical Development, Biometrics, Medical Affairs, and Regulatory leaders to develop and maintain project plans, timelines, and dashboards for multiple clinical programs aligned with department and corporate objectives.
• Identify, score, and communicate risks through maintained risk registers with proactive mitigation and contingency plans; ensure department timelines and risk trackers integrate with the corporate portfolio and integrated roadmaps.
• Manage CROs, vendors, and external partners by tracking performance and contracts, escalating and resolving issues, leading vendor governance meetings, and cultivating durable relationships focused on on-time, quality delivery.
• Support preparation and submission of regulatory filings, including INDs and BLAs, in partnership with Clinical, Regulatory Affairs, Technical Development, and Supply Chain.
• Prepare and present project updates to senior management and key stakeholders to support decision-making; partner with Finance and Legal to facilitate on-time, on-budget milestone delivery.
• Advance enterprise PMO best practices by creating and using PM tools and templates that support continuous improvement and scalable processes.
• Serve as Smartsheet Super User by building and publishing project and portfolio-level plans, dashboards, and reports, and training team members on Smartsheet functionality.
• Work across time zones as necessary; travel 10–15% may be required; other duties as assigned.

Requirements

• Experience in pharmaceutical or biotechnology industries is required.
• 7+ years of program management experience is required for Sr. Manager level; 8+ years is required for Associate Director level.
• Technical operations experience and cell and gene therapy, CAR-T, or similar industry experience are preferred.
• Direct experience supporting regulatory Health Authority Inspections in a GxP-regulated environment is required.
• Proficiency in MS Office, including Outlook, PowerPoint, Excel, and Word, and familiarity with project management tools are required.
• Strong understanding of PM best practices, PMO operating models, and scalable processes in a growing corporate environment is required.
• Extensive Smartsheet experience, including creating, maintaining, and reporting timelines, Gantt charts, dashboards, and reports.
• Excellent external-facing presence and experience 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 PM culture.

Preferred Qualifications

• Advanced degree in Life Sciences is preferred.
• Certification in project management, such as PMP or CAPM, is preferred.
• Experience with both early- and late-stage clinical programs is an advantage.
• Cell and gene therapy, CAR-T, or similar industry experience is preferred.

Benefits

• Competitive benefits
• Paid time off (PTO)
• Stock option plans