Sr. Director, Safety & Pharmacovigilance

Kyverna Therapeutics; United States; Hybrid; USD 320,000 - 350,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Pharmacovigilance

Leadership

Regulatory affairs

Cross-functional collaboration

Safety signal detection

Education

MD degree

Job description

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Title: Sr. Director, Safety and Pharmacovigilance

Location: Remote or Emeryville, CA (Hybrid)
Reports to: SVP, Head of Global Safety and Pharmacovigilance

Summary

The Sr Director, Safety Physician, will play a key role in the global safety strategy and execution for the Company’s cell therapy pipeline. Experience with clinical safety and strategy in development is a must. The incumbent is responsible for ensuring proactive signal detection, risk management, regulatory compliance, and cross-functional collaboration to support clinical and regulatory strategies for the assigned product or indications. The ideal candidate brings deep expertise in cell and gene therapy, strong CNS (MS, MG) experience, regulatory acumen, and experience operating in a lean, fast-moving biotech environment.

Responsibilities

• Serve as the safety subject-matter expert for cell therapy programs for MS, MG and other indications as needed, including novel and emerging risks
• Provide strategic safety input to clinical development plans, protocols, investigator brochures, and regulatory submissions
• Act as a key member of cross-functional governance and program teams
• Oversee all medical safety activities including individual case assessment, signal detection, risk management, and aggregate reporting for assigned indications or products
• Lead safety surveillance activities and ongoing benefit-risk assessments
• Review and approve safety data, medical assessments, and regulatory safety documents
• Contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and internal safety governance forums for assigned products or indications
• Lead safety signal evaluation, escalation, and documentation
• Ensure compliance with global safety regulations (FDA, EMA, ICH, CIOMS, local health authorities)
• Partner with team lead for regulatory interactions, inspections, and audits
• Author or oversee safety sections of INDs and BLAs, and responses to health authority inquiries for assigned products or indications
• Partner with team members to maintain PV SOPs, processes, and inspection readiness
• Proactively identify and mitigate safety risks associated with cell therapy modalities
• Contribute to the operational excellence, continuous improvement of the GSP department’s initiatives

Qualifications

• MD degree
• 8+ years of experience in pharmacovigilance and drug safety, with at least 3 years in a leadership role
• Direct experience supporting cell therapy, gene therapy, or experience with autoimmune or CNS indications, such as MS or MG strongly preferred
• Experience in clinical-stage biotech; prior BLA/MAA and/or launch experience is a plus
• Demonstrated success interacting with global regulatory agencies on safety matters
• Strong knowledge of global PV regulations and safety standards
• Strategic thinker with the ability to operate hands-on in a lean organization
• Excellent cross-functional leadership and communication skills
• Proven ability to balance compliance, scientific rigor, and business priorities

The national base salary range for this position is $320K-$350K annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data. This position is also eligible for bonus, benefits, and participation in the company’s stock plan.