Cabaletta Bio

Medical Director

• Serve as senior Data Management Lead for assigned clinical studies across multiple phases, from protocol review through database lock, long-term follow-up, and archival
• Review protocols and study strategies to ensure feasible, compliant, and effective data collection
• Lead EDC, CRF, edit check, query logic, user requirements, and CRF completion guideline development
• Oversee external data integrations, transfers, reconciliation, medical coding, and validation
• Develop and maintain data management plans, database specifications, validation records, UAT documentation, and data review plans
• Lead cross-functional data review and align stakeholders on quality, timelines, and risk mitigation
• Oversee CROs and vendors, including selection, performance, quality, timelines, budgets, and change orders
• Drive study and program milestones, identify risks, and implement solutions
• Lead database testing, UAT, data cleaning, coding, reconciliation, database lock, and archival
• Review data listings and support analyses, safety monitoring committees, endpoint adjudication, and submissions
• Support regulatory submissions, health authority responses, inspection readiness, and audits
• Ensure compliance with GCP, FDA and ICH requirements, company procedures, industry standards, and CDISC standards
• Contribute to data standards, SOPs, technology assessments, and continuous process improvement
• Provide leadership, mentoring, and technical guidance to data management staff
• Represent Clinical Data Management on cross-functional teams and communicate status, risks, and resource needs

Associate Director, Clinical Data Management

Business Development Rep

• Reporting to the Chief Business Officer, the Senior Director, Business Development will play a central role in identifying, evaluating, negotiating, and executing strategic partnerships that strengthen Cabaletta Bio's leadership in engineered cell therapies for autoimmune diseases
• Lead business development and alliance management activities across licensing, acquisitions, platform collaborations, and strategic partnerships while working closely with Research, Development, Clinical, Commercial, Legal, Finance, and Executive Leadership
• Identify and evaluate external opportunities including licensing, acquisitions, strategic collaborations, platform technologies, and co-development partnerships
• Continuously assess the competitive landscape to identify emerging scientific and commercial opportunities aligned with Cabaletta's strategic priorities, including product expansion, geographic expansion, and lifecycle management strategies
• Develop business development strategies that support both near-term pipeline expansion and long-term platform growth
• Lead scientific, clinical, commercial, operational, intellectual property, and financial diligence for potential transactions
• Build integrated commercial and financial models to evaluate strategic fit, market opportunity, probability-adjusted value, and return on investment
• Prepare investment recommendations and executive-level presentations for the Executive Leadership Team and Board of Directors
• Lead cross-functional transaction teams through all phases of partnering activities
• Develop and maintain relationships with biotechnology companies, academic institutions, CDMOs and potential strategic partners

Senior Director, Business Development

General Counsel

• Translate complex legal and regulatory requirements into practical, business-oriented advice for internal stakeholders.
• Proactively support a broad range of functions within the Company, with a primary focus on Clinical Operations, Medical Affairs, Research, Commercial.
• Draft, review, and negotiate a wide variety of agreements including: clinical trial agreements and related informed consent forms and protocols; research and development agreements; manufacturing and supply agreements; consulting agreements; service agreements; and material transfer agreements for activities in the U.S., Canada, EU and UK.
• Provide legal support for certain commercial activities ahead of commercial launch, including serving as reviewer on promotional review committees and advising on compliance matters, including HCP engagements, speaker programs, advisory boards, grants, charitable contributions, sponsorships, consultant arrangements, and interactions with healthcare organizations.
• Advise on U.S. privacy and EU / UK GDPR issues as they relate to clinical trial participant, patient and employee data.
• Collaborate with cross-functional teams to ensure regulatory compliance across relevant aspects of the business, including clinical trials, FDA regulations, GCP requirements and healthcare compliance.
• Support the development of Company policies and promote ethical practices; and support the implementation of the compliance program throughout the organization.

Senior Director, Assistant General Counsel

Sales

• Partner with the Chief Commercial Officer to develop and execute the commercial strategy for rese-cel, including market development, customer engagement, brand strategy, and launch readiness activities.
• Lead commercialization planning and execution to ensure successful launch preparation and market adoption.
• Translate commercial strategy into actionable sales and marketing plans, objectives, and performance metrics.
• Provide customer, market, and competitive insights to inform commercial decision-making and launch planning.
• Support forecasting, business planning, and commercial analytics activities.
• Build, lead, and develop a high-performing Sales and Marketing organization capable of supporting a successful launch and long-term growth.
• Develop organizational structure, hiring plans, talent strategies, and capability-building programs for commercial functions.
• Establish performance expectations and foster a culture of accountability, collaboration, and execution excellence.
• Lead launch planning and execution for rese-cel, including field force design, deployment strategy, promotional planning, customer engagement, and treatment center activation.
• Partner with Market Access to support payer engagement strategies, reimbursement readiness, and site-of-care considerations.
• Collaborate with Operations, Manufacturing, and Patient Services teams to ensure commercial readiness for the unique logistical and operational requirements of cell therapy delivery.
• Help establish customer-facing processes supporting patient identification, treatment center engagement, scheduling, chain of identity, and chain of custody.
• Partner closely with Medical Affairs to ensure scientifically accurate and compliant promotional messaging and educational initiatives.
• Collaborate with IT to develop and implement commercial systems, CRM platforms, order management capabilities, and analytics tools required to support launch execution.
• Work closely with Regulatory, Legal, Compliance, and Quality partners to ensure all commercial activities meet applicable legal and regulatory requirements.
• Serve as a key member of the Commercial Leadership Team and contribute to broader company initiatives and strategic planning.
• Build and maintain strong relationships with key opinion leaders, treatment centers, advocacy organizations, and other critical stakeholders.
• Represent the company at industry, scientific, and commercial meetings as appropriate.
• Monitor market dynamics, competitive activities, and evolving customer needs to identify opportunities and risks.
• Develop and manage commercial budgets and resource plans in alignment with organizational priorities.
• Ensure effective and efficient deployment of commercial investments to achieve launch and business objectives.

Associate Director, Clinical Data Management

Senior Director, Business Development

Senior Director, Assistant General Counsel

Senior Vice President, Sales & Marketing