Senior Director, Global Safety & PV — Remote

Kyverna Therapeutics; Emeryville (CA); Hybride; USD 320 000 - 350 000; Plein temps

Avantages offerts par ce poste

Bonus

Stock plan

Benefits

Résumé du poste

Kyverna Therapeutics is seeking a Sr. Director, Safety to lead global safety strategy for its cell therapy programs. The role requires deep clinical safety experience in development, proactive signal detection, risk management, and regulatory collaboration to support INDs/BLAs.

Ideal candidate has CNS indications experience and a track record with regulatory agencies in a fast-moving biotech environment. Reporting to the SVP, Head of Global Safety and Pharmacovigilance, you will oversee safety

Qualifications

• MD degree required; leadership in pharmacovigilance preferred.
• Experience leading safety teams in cell therapy or gene therapy.
• Experience with regulatory submissions (INDs/BLAs) and global agencies.

Responsabilités

• Lead global safety strategy for cell therapy programs.
• Provide strategic safety input to development plans and regulatory submissions.
• Oversee safety surveillance, signal detection, and risk management.
• Ensure compliance with FDA/EMA/ICH and health authorities.
• Lead safety governance forums and data review activities.
• Collaborate with cross-functional teams and regulators.

Connaissances

Leadership

Cross-functional collaboration

Regulatory strategy

Safety signal detection

Clinical safety

Formation

MD degree

Description du poste

Kyverna Therapeutics is seeking a Sr. Director, Safety to lead global safety strategy for its cell therapy programs. The role requires deep clinical safety experience in development, proactive signal detection, risk management, and regulatory collaboration to support INDs/BLAs.

Ideal candidate has CNS indications experience and a track record with regulatory agencies in a fast-moving biotech environment. Reporting to the SVP, Head of Global Safety and Pharmacovigilance, you will oversee safety