Director, Pharmacovigilance

Director Pharmacovigilance

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 Bios headquarters and labs are located in Philadelphia PA. For more information please visit

and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta we are driven by the shared mission of developing cures where a patients 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 this way we are not only working to improve the lives of patients but of everyone involved. #CabalettaCrew.

Were 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 810 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).
• Prior experience in cell and gene therapy immunology or related therapeutic areas strongly preferred.
• 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.
• Experience working in or with early-stage or growth-stage biotech companies preferred.
• Excellent analytical communication and problem-solving skills.
• Strong attention to detail and commitment to quality and patient safety.

Our name Cabaletta is derived from the operatic term that represents a rapid repetitive and technically challenging section of an operatic aria designed to showcase the skills of the lead singer. Analogously Cabaletta Bio strives to achieve rapid and repetitive product development building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information please visit most important asset is our people and we offer competitive benefits PTO and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race color gender gender identity sexual orientation age religion national or ethnic origin disability protected veteran status or any other basis protected by applicable law.

Cabaletta Bio Inc. does not accept unsolicited resumes from recruiters employment agencies or staffing firms. To conduct business with Cabaletta a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And if a resume or candidate is submitted by a recruiter an employment agency or a staffing firm without a fully executed MSA Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter agency and/or firm.

#LI-REMOTE