Director, Pharmacovigilance

Cabaletta Bio; Philadelphia (Philadelphia County); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health and retirement benefits

PTO

Stock option plans

Job summary

Cabaletta Bio is seeking a Director of Pharmacovigilance to lead safety and regulatory compliance for clinical-stage CAR-T programs. This role entails overseeing pharmacovigilance strategies, managing safety data collection, and ensuring operational excellence. Ideal candidates will have an advanced degree and 8-10 years of relevant experience, notably in biotech. The position offers hybrid or remote work options and comes with competitive benefits including health, retirement, and stock options.

Qualifications

• 8–10 years of pharmacovigilance/safety experience in biotech or pharmaceutical industry.
• Knowledge of global pharmacovigilance regulations (FDA, EMA, ICH).
• Experience in cell and gene therapy preferred.

Responsibilities

• Lead pharmacovigilance strategy across clinical programs.
• Ensure compliance with pharmacovigilance regulations.
• Establish and refine PV processes and systems.

Skills

Pharmacovigilance experience

Strong analytical skills

Communication skills

Collaboration in matrixed environments

Attention to detail

Education

Advanced degree (MD, PharmD, PhD)

Job 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.

Responsibilities Include

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).
• 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.

Required 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 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 most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

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.