Cabaletta Bio

Director

• Lead product-focused new product planning across early- and late-stage programs, including definition and evolution of Target Product Profiles (TPPs)
• Design and oversee qualitative and quantitative market research to inform product design, indication prioritization, and differentiation strategy
• Translate customer, payer, and market insights into clear product requirements and strategic recommendations for development teams
• Partner with Clinical Development, Regulatory, and Medical Affairs to ensure development plans reflect real-world market needs and constraints
• Assess competitive landscapes, evolving standards of care, and emerging data to guide product positioning and lifecycle planning
• Develop product narratives articulating clinical value, unmet need, and differentiation
• Support portfolio prioritization through product-level assessments, scenario analyses, and value framing
• Prepare and present product strategy updates to governance forums and senior leadership
• Establish best practices, tools, and frameworks for product planning and insight generation across the portfolio

Associate Director, Statistical Programming

Program Manager

• Lead strategic planning, execution, and delivery of clinical programs across Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Regulatory
• Align program planning and execution with corporate objectives and 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 tracking
• Maintain project plans, timelines, and dashboards for multiple clinical programs
• Identify, score, communicate, and mitigate program risks using risk registers and contingency plans
• Manage CROs, vendors, and external partners, including performance, contracts, governance, and issue resolution
• Support regulatory filings, including INDs and BLAs
• Prepare and present project updates to senior management and stakeholders
• Partner with Finance and Legal to facilitate on-time, on-budget milestone delivery
• Advance PMO best practices through scalable tools, templates, and processes
• Serve as Smartsheet Super User by building plans, dashboards, and reports and training team members
• Work across time zones; travel 10–15% may be required

Senior Manager, Program Management – Clinical, Medical & Regulatory

Data Analyst

• Partner with CMC subject matter experts to identify scientific and technical questions addressable through data science, data integration, visualization, statistical analysis, and modeling
• Integrate and analyze data across process development, analytical development, manufacturing, raw materials, and product quality
• Develop visualizations, dashboards, and analytical workflows for data exploration, trend identification, and decision-making
• Establish scalable and reproducible approaches for organizing, integrating, analyzing, and visualizing CMC data
• Apply statistical and computational tools such as JMP, Python, R, SQL, Spotfire, Power BI, or similar platforms
• Explore advanced analytics, automation, machine learning, and AI-enabled approaches for CMC challenges
• Lead data-focused projects from problem definition and data assessment through analysis, interpretation, visualization, and communication
• Work with complex and imperfect datasets and structure ambiguous scientific questions
• Communicate analytical approaches, assumptions, limitations, and conclusions to technical and non-technical stakeholders
• Develop reusable analytical workflows, tools, and best practices across Technical Development
• Collaborate across functions and contribute to continuous learning, accountability, and open communication
• Perform other related duties as assigned

Associate Director, Statistical Programming

Senior Manager, Program Management – Clinical, Medical & Regulatory

Senior Data Scientist, Technology Development, Data Analytics