Associate Director, Program Management – Clinical, Medical & Regulatory

About the role

Cabaletta Bio is hiring a Senior Manager / Associate Director, Program Management – Clinical, Medical & Regulatory, reporting through the Sr. Director, Program Management to the PMO. The role leads the strategic planning, execution and delivery of clinical programs that unite Clinical Development, Clinical Operations, Biometrics, Medical Affairs and Regulatory functions, working as an embedded, matrixed member of the CMR organization. It is open to remote or Philadelphia, PA candidates.

Key responsibilities

• Work with the CMR portfolio PM and lead Asset PM to align program planning and execution with corporate objectives and the Product Development Team 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 and action-item tracking.
• Partner with Clinical Operations, Clinical Development, Biometrics, Medical Affairs and Regulatory leaders to maintain project plans, timelines and dashboards.
• Identify, score and communicate risks through risk registers, with proactive mitigation and contingency plans.
• Manage CROs, vendors and external partners, tracking performance and contracts, escalating issues and leading vendor governance meetings.
• Support preparation and submission of regulatory filings, including INDs and BLAs.
• Present project updates to senior management and work with Finance and Legal to support on-time, on-budget milestones.
• Create PM tools and templates, and act as Smartsheet Super User, building plans, dashboards and reports and training team members.

Required profile

• Experience in pharmaceutical or biotechnology industries is required.
• 7+ years of program management experience for Sr. Manager level, 8+ years for Associate Director level.
• Direct experience supporting regulatory Health Authority inspections in a GxP-regulated environment is required.
• Preferred: technical operations experience, cell and gene therapy, CAR-T or similar industry experience, and experience with early- and late-stage clinical programs.

Required skills

• Proficiency in MS Office (Outlook, PowerPoint, Excel, Word).
• Extensive Smartsheet experience, including Gantt charts, dashboards and reports.
• Familiarity with project management tools and PMO operating models.

What we offer

• Health and retirement benefits.
• PTO.
• Stock option plans.