Senior Director, Safety & Pharmacovigilance

Kyverna Therapeutics

. Serve as the safety subject-matter expert for cell therapy programs for MS, MG and other indications as needed, including novel and emerging risks .

Posted 10/7/2026full-timeRemote • California • United StatesSenior💰 $320,000 - $350,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in pharmacovigilance and drug safety with a focus on cell therapy programs, including risk management, regulatory compliance, and cross-functional leadership. Proven ability to navigate global safety regulations and contribute to clinical development strategies.

Highest-signal resume keywords

PharmacovigilanceCell Therapy ExperienceRegulatory ComplianceCross-Functional LeadershipRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety Data ReviewSignal DetectionBenefit-Risk AssessmentAggregate ReportingIND AuthoringBLA OversightClinical Development PlanningSafety SurveillanceMedical Safety ActivitiesRegulatory Submissions

Soft Skills

Cross-Functional CommunicationLeadershipStrategic Input

Certifications & Qualifications

MD Degree

Industry Keywords

FDA RegulationsEMA RegulationsICH GuidelinesCIOMS StandardsPharmacovigilance SOPsClinical-Stage BiotechAutoimmune IndicationsCNS IndicationsData Monitoring CommitteesSafety Review Committees

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Bonus eligibility
Benefits
Participation in the company’s stock plan