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.
