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

Role: Lead strategic planning and execution of clinical programs within Cabaletta Bio's cell and gene therapy pipeline, focusing on autoimmune disease treatments like rese-cel. Responsibilities: oversee cross-functional teams (Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Regulatory), develop project scope, timelines, budgets, and risk management strategies; manage vendor relationships; support regulatory filings (INDs, BLAs); prepare project updates for senior management; optimize PM processes and tools, especially with Smartsheet; ensure alignment with corporate and portfolio goals. Requirements: 7+ years (Sr. Manager) or 8+ years (Assoc. Director) program management experience in biotech/pharmaceuticals, with direct GxP and regulatory inspection support experience; proficiency in MS Office and project management tools, especially Smartsheet; strong leadership, communication, and stakeholder management skills. Preferred: advanced life sciences degree, PMP or CAPM certification, experience in cell/gene therapies like CAR-T, prior involvement in early- and late-stage clinical programs. HighValue: biotech or pharma experience, expertise supporting regulatory inspections, cell/gene therapy modalities, clinical trial phases from early to late, cross-functional collaboration, and vendor management. WorkSetup: hybrid Philadelphia, PA; travel 10–15%.