Senior Director, Safety & Pharmacovigilance

🕒 October 7

🏄 California – Remote

🏄 California – Remote

💵 $320k - $350k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 7%

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• 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 medical safety activities including individual case assessment, signal detection, risk management, and aggregate reporting • 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, Data Monitoring Committees, and internal safety governance forums • Lead safety signal evaluation, escalation, and documentation • Ensure compliance with global safety regulations including FDA, EMA, ICH, CIOMS, and local health authorities • Partner with the team lead for regulatory interactions, inspections, and audits • Author or oversee safety sections of INDs and BLAs, and responses to health authority inquiries • 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 operational excellence and continuous improvement initiatives of the GSP department

🎯 Requirements

• MD degree • 12+ years of experience in pharmacovigilance and drug safety, with at least 5 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 • 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

🏖️ Benefits

• Bonus eligibility • Benefits • Participation in the company’s stock plan

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