Director, Pharmacovigilance

Title: Director, Pharmacovigilance Location: Philadelphia, PA Department: Drug Safety/Pharmacovigilance Job Description: Remote Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work® Position Description: This role can be based out of our Philadelphia, PA headquarters, hybrid, or remote. Reporting into the VP, Clinical Development, the Director, Pharmacovigilance will lead and execute global safety and pharmacovigilance activities across clinical-stage CAR-T programs in autoimmune diseases. This role is responsible for ensuring high-quality safety data collection, analysis, and reporting in compliance with global regulatory requirements, while partnering cross-functionally to support clinical development and future regulatory submissions. This is a highly collaborative and hands-on role, working closely with Medical Directors, Clinical Scientists, Clinical Operations, Regulatory, and Medical Affairs to proactively identify, evaluate, and communicate safety signals. The ideal candidate thrives in a fast-paced, evolving environment and is equally comfortable setting strategy and diving into execution. Key Responsibilities: Safety Strategy & Oversight

• Lead pharmacovigilance strategy across clinical programs, ensuring alignment with overall clinical development plans.
• Serve as the safety lead on study teams, providing medical and scientific input on safety data interpretation and risk management.
• Contribute to the development and maintenance of safety-related documents, including DSURs, IBs, protocols, and safety sections of regulatory submissions (e.g., INDs/BLAs).

Case Management & Signal Detection

• Oversee case processing activities, including SAE review, medical assessment, and timely reporting in compliance with global regulations.
• Lead signal detection, evaluation, and risk assessment activities, including aggregate data review and benefit-risk evaluation.
• Ensure appropriate escalation and communication of safety signals to internal stakeholders and governance committees.

Regulatory Compliance & Inspection Readiness

• Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines.
• Support health authority interactions related to safety and pharmacovigilance.
• Contribute to inspection readiness activities and support audits and inspections as needed.

Cross-Functional Collaboration

• Partner closely with Clinical Development, Clinical Operations, Regulatory, and Medical Affairs to ensure integrated safety oversight across programs.
• Provide safety input into clinical trial design, study conduct, and data review processes.
• Collaborate with external vendors (e.g., CROs, safety databases) to ensure high-quality PV operations.

Operational Leadership

• Establish and refine pharmacovigilance processes, systems, and infrastructure to support a growing clinical pipeline.
• Oversee PV vendors and ensure performance, quality, and compliance.
• Contribute to building scalable PV capabilities in preparation for late-stage development and potential commercialization.

Qualifications:

• Advanced degree (MD, PharmD, PhD, or equivalent) in a relevant scientific or medical discipline preferred.
• Minimum of 8–10 years of pharmacovigilance/safety experience in biotech or pharmaceutical industry, including clinical-stage programs.
• Strong kno

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