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

Position Title:
Sr. Manager / Associate Director, Program Management – Clinical, Medical & Regulatory

Location:
Hybrid/Philadelphia, PA

Reports to:
Sr. Director, Program Management

Department:
Program Management Office

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.

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  and connect with us on Linked In.

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. #Cabaletta Crew.

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 commensurate with 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.

The ideal candidate brings 7+ years of program management experience for Sr. Manager level or 8+ years for Associate Director level in clinical trial environments within biotech or cell and gene therapy, advanced strategic planning skills, strong cross‑functional leadership, and high proficiency in Smart Sheet.

• 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…