Associate Director, Program Management – Clinical, Medical & Regulatory

🔥 1 minute ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

📋 Program Manager

👻 Ghost score 11%

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Cabaletta Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies to treat autoimmune diseases. Using its CABA® (Cabaletta Approach to B cell Ablation) platform, the company is advancing rese-cel, a fully human CD19 CAR T cell candidate with a 4-1BB co-stimulatory domain, in multiple RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. Cabaletta aims to deliver deep, durable, potentially curative responses by transiently eliminating B cells to reset immune tolerance, and emphasizes patient-centered development and broad indication expansion across rheumatology, dermatology, and neurology.

📋 Description

• 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-item tracking • Develop and maintain project plans, timelines, and dashboards for multiple clinical programs • Identify, score, and communicate risks through risk registers with mitigation and contingency plans • Manage CROs, vendors, and external partners, including performance, contracts, issue resolution, and vendor governance • Support preparation and submission of 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 • Create and use PM tools and templates to advance enterprise PMO best practices • Serve as Smartsheet Super User by building and publishing plans, dashboards, and reports and training team members • Work across time zones as necessary; travel 10–15% may be required

🎯 Requirements

• 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 • Proficiency in MS Office, including Outlook, PowerPoint, Excel, and Word, and familiarity with project management tools • Strong understanding of PM best practices, PMO operating models, and scalable processes • Extensive Smartsheet experience, including creating, maintaining, and reporting timelines, Gantt charts, dashboards, and reports • Experience managing vendor relationships and contracts • Strong verbal and written communication skills • Ability to manage multiple tasks and priorities • Ability to work independently and collaboratively with cross-functional teams • Experience in clinical trial environments within biotech or cell and gene therapy • Advanced degree in Life Sciences is preferred • Certification in project management, such as PMP or CAPM, is preferred • Experience with early- and late-stage clinical programs is an advantage • Cell and gene therapy, CAR-T, or similar industry experience is preferred • Authorization to work in the United States is addressed in the application

🏖️ Benefits

• Competitive benefits • PTO • Stock option plans • Commitment to employee well-being and continuous growth • Great Place to Work-Certified company