Senior Director, Global Safety & Pharmacovigilance (Remote)

Kyverna Therapeutics; United States; Hybrid; USD 320.000 - 350.000; Vollzeit

Zusammenfassung

Kyverna Therapeutics is seeking a Sr. Director, Safety and Pharmacovigilance to lead global safety strategy for the cell therapy pipeline.

The role requires expert clinical safety experience in development, proactive signal detection, risk management, and regulatory compliance in a lean biotech setup. Ideal candidates will have an MD, 8+ years in PV with 3+ in leadership, and strong CNS/cell therapy exposure.

Qualifikationen

• MD degree and 8+ years in pharmacovigilance/drug safety.
• At least 3 years in a leadership role.
• Experience supporting cell therapy, gene therapy, or autoimmune/CNS indications.
• Clinical-stage biotech PV; BLA/MAA and/or launch experience a plus.
• Proven success with global regulatory agencies on safety matters.
• Strong cross-functional leadership and communication skills.

Aufgaben

• Serve as safety SME for cell therapy programs (MS, MG and other indications).
• Provide strategic safety input to development plans, protocols, and regulatory submissions.
• Act as a key member of cross-functional governance and program teams.
• Oversee safety activities including case assessment, signal detection, risk management, reporting.
• Lead safety surveillance and ongoing benefit-risk assessments.
• Review and approve safety data, medical assessments, and regulatory documents.
• Contribute to SRCs, DMCs, and internal safety governance forums.
• Lead safety signal evaluation, escalation, and documentation.
• Ensure compliance with FDA, EMA, ICH, CIOMS, and local authorities.
• Partner on regulatory interactions, inspections, and audits.
• Author/oversee safety sections of INDs/BLAs and responses to inquiries.
• Maintain PV SOPs and inspection readiness.
• Identify and mitigate safety risks in cell therapy modalities.
• Contribute to operational excellence and PV initiatives.

Kenntnisse

Pharmacovigilance

Leadership

Regulatory affairs

Cross-functional collaboration

Safety signal detection

Ausbildung

MD degree

Jobbeschreibung

Kyverna Therapeutics is seeking a Sr. Director, Safety and Pharmacovigilance to lead global safety strategy for the cell therapy pipeline.

The role requires expert clinical safety experience in development, proactive signal detection, risk management, and regulatory compliance in a lean biotech setup. Ideal candidates will have an MD, 8+ years in PV with 3+ in leadership, and strong CNS/cell therapy exposure.