Director, Pharmacovigilance

Cabaletta Bio Inc.•Philadelphia, PA

16h•Remote

About The Position

Cabaletta Bio is a clinical-stage biotechnology company focused on developing and launching curative targeted cell therapies for patients with autoimmune diseases. The CABA™ platform aims to advance engineered T cell therapies with the potential for deep and durable treatments. The lead CARTA strategy is developing rese-cel, a CD19-CAR T cell investigational therapy, currently in the RESET™ clinical development program across rheumatology, neurology, and dermatology. This Director, Pharmacovigilance role will lead and execute global safety and pharmacovigilance activities for clinical-stage CAR-T programs in autoimmune diseases. The role ensures high-quality safety data collection, analysis, and reporting in compliance with global regulatory requirements, partnering cross-functionally to support clinical development and future regulatory submissions. It is a highly collaborative and hands-on position, working closely with Medical Directors, Clinical Scientists, Clinical Operations, Regulatory, and Medical Affairs to proactively identify, evaluate, and communicate safety signals. Cabaletta Bio fosters a culture grounded in team success, employee well-being, and continuous growth, and is a Great Place to Work-Certified™ company.

Requirements

Minimum of 8–10 years of pharmacovigilance/safety experience in biotech or pharmaceutical industry, including clinical-stage programs.
Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH).
Experience supporting clinical trials, including safety monitoring, signal detection, and aggregate reporting (e.g., DSURs).
Demonstrated ability to work cross-functionally and influence without authority in a matrixed environment.
Proven ability to operate both strategically and hands-on in a fast-paced, resource-constrained setting.
Excellent analytical, communication, and problem-solving skills.
Strong attention to detail and commitment to quality and patient safety.

Nice To Haves

Advanced degree (MD, PharmD, PhD, or equivalent) in a relevant scientific or medical discipline preferred.
Prior experience in cell and gene therapy, immunology, or related therapeutic areas strongly preferred.
Experience working in or with early-stage or growth-stage biotech companies preferred.

Responsibilities

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).
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.
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.
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.
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.