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Sr. Director, Corporate Compliance

Kyverna Therapeutics

Emeryville, CARemoteJob$265–285K/yrPosted 1mo agoVerified open 3 days ago

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At a glance

Compensation
$265–285K/yr
Location
Emeryville, CARemote
Work Authorization
Not specified

Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Kyverna Therapeutics is hiring a Sr. Director, Corporate Compliance. Kyverna Therapeutics seeks a Sr. Director of Corporate Compliance to develop and lead an enterprise compliance program as the company moves from clinical to commercial stages, establishing vision, strategy, governance, and operations that support responsible growth, commercial readiness, and an ethics‑driven culture.

Key focus areas include Serve as program manager for enterprise compliance buildout and commercialization-readiness initiatives, coordinating cross-functional workstreams and reporting., Develop and execute enterprise compliance program strategy and roadmap in partnership with the Chief Legal Officer., and Lead day-to-day operations of the Compliance function, establishing scalable governance, policies, systems, and processes..

Successful candidates bring Bachelor's Degree In Business, Life Sciences, Healthcare Administration, Or Related Field, 12+ Years Progressive Experience In Pharmaceutical, Biotechnology, Medical Device, Or Healthcare Compliance, and Experience Supporting Commercial Organizations. Important skills include Enterprise Compliance Program Development, Risk-Based Compliance Program, Commercial Readiness, Ethics And Integrity Culture, Program Management, and Cross-Functional Workstream Coordination.

Skills & qualifications

RequiredNice to have

Skills

Enterprise Compliance Program DevelopmentRisk-Based Compliance ProgramCommercial ReadinessEthics and Integrity CultureProgram ManagementCross-Functional Workstream CoordinationCompliance Program Strategy DevelopmentCompliance Function OperationsScalable GovernanceHealthcare ComplianceHHS Office of Inspector General's General Compliance Program GuidanceStrategic Thought PartnerCompliance Risk IdentificationRegulatory Trend AnalysisCompliance Metrics and ReportingOrganizational Structure RecommendationTalent RecommendationCompliance Integration Into Business OperationsPrivacy-Related Compliance ProcessesFDA Promotional RequirementsAnti-Kickback StatuteFalse Claims ActSunshine Act/Open PaymentsPhRMA CodeHIPAAThird-Party Compliance DiligenceThird-Party OnboardingThird-Party MonitoringThird-Party RecertificationRisk ManagementBusiness EnablementRegulatory CompliancePolicy and Standard EstablishmentGovernance Process EstablishmentCompliance Education and CommunicationsEnterprise Compliance Risk AssessmentsMonitoring ActivitiesCompliance Reporting Channels ManagementCase-Intake Processes ManagementInvestigation Protocols ManagementInvestigations OversightCorrective Actions OversightRemediation Plans OversightProgram Effectiveness MeasurementData and Metrics AnalysisPeriodic Program AssessmentsStrategic LeadershipExecutionTrusted Relationships DevelopmentInfluence Decision-Making

Qualifications

Bachelor's Degree in Business, Life Sciences, Healthcare Administration, or Related Field12+ Years Progressive Experience in Pharmaceutical, Biotechnology, Medical Device, or Healthcare ComplianceExperience Supporting Commercial OrganizationsSuccess Building, Standing Up, or Significantly Enhancing Enterprise Compliance Programs Within a Growing Clinical-Stage to Commercial-Stage Biotechnology OrganizationAdvanced Degree (JD, MBA, MPH, MS, or Equivalent)

Benefits

Medical Insurance

Full 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, Corporate Compliance Reports to : Chief Legal and Compliance Officer Location : Emeryville, CA (Hybrid) or west coast remote

The Sr. Director, Corporate Compliance is responsible for developing and leading the company's enterprise compliance program as the organization transitions from clinical to commercial stage. This role establishes the vision, strategy, governance, and operations of a scalable, risk-based compliance program that supports responsible business growth, commercial readiness, and a culture of ethics and integrity.

As a strategic leader and player-coach, the Sr. Director, Corporate Compliance provides enterprise-wide compliance leadership while remaining actively engaged in building and executing the program. Serving as a key member of the Legal leadership team, this role partners with executive leaders and cross-functional stakeholders to integrate compliance into the corporate strategy and business operations, proactively manage regulatory and ethical risk, and build the foundation for a high-performing Compliance function as the organization grows and transition into commercial stage.

Responsibilities

  • Serve as the program manager for Kyverna’s enterprise compliance buildout and commercialization-readiness initiatives, coordinating cross-functional workstreams, owners, milestones, dependencies, deliverables, status reporting, and escalation of material blockers and risks.

  • Develop and execute the enterprise compliance program strategy and roadmap, in partnership with and under the direction of the Chief Legal Officer, aligning program priorities with corporate objectives and commercial-readiness milestones.

  • Lead the day-to-day operations of the Compliance function, establishing scalable governance, policies, systems, and processes that support sustainable organizational growth.

  • Build and continuously enhance a risk-based enterprise compliance program, including healthcare compliance, aligned with the seven elements of an effective compliance program described in the HHS Office of Inspector General’s General Compliance Program Guidance .

  • Serve as a strategic thought partner to the Chief Legal Officer and executive leadership team, influencing corporate strategy by proactively identifying compliance risks, regulatory trends, and opportunities that impact business decisions.

  • Establish meaningful compliance metrics and reporting to evaluate program effectiveness, inform executive decision-making, and drive continuous improvement.

  • Build the Compliance function over time, recommending organizational structure, talent, and capabilities to support the company's evolving business needs.

  • Partner with Commercial, Medical Affairs, Clinical Development, Regulatory Affairs, Market Access, Human Resources, Finance, Privacy, Legal, and other business leaders to embed compliance into business operations. Work closely with Legal on privacy-related compliance processes and escalate privacy legal issues to the appropriate Legal lead.

  • Provide practical guidance on healthcare compliance risks related to commercialization, including interactions with healthcare professionals, promotional activities, patient support programs, grants, speaker programs, and transparency requirements.

  • Establish risk-based third-party compliance diligence, onboarding, monitoring, and recertification processes, and partner with Legal and business teams on compliance requirements and escalation procedures for higher-risk consultants, vendors, distributors, service providers, and strategic partners.

  • Balance effective risk management with business enablement, supporting innovation while maintaining regulatory compliance. Lead the development and ongoing effectiveness of the company's compliance program by:

  • Establishing policies, standards, and governance processes.

  • Developing compliance education and communications that promote ethical decision-making and a culture of integrity.

  • Conducting enterprise compliance risk assessments and implementing monitoring activities to evaluate program effectiveness.

  • Establish and manage compliance reporting channels, case-intake processes, and investigation protocols; oversee investigations, corrective actions, remediation plans, and continuous improvement initiatives.

  • Measuring program effectiveness through data, metrics, and periodic program assessments.

  • Operate as a strategic leader while remaining actively involved in execution during the company's growth phase. •

  • Develop trusted relationships across the organization and influence decision-making through collaboration, credibility, and sound judgment.

  • Manage external compliance advisors, consultants, and the compliance budget, as appropriate, while establishing internal capabilities. Qualifications

  • Bachelor's degree in Business, Life Sciences, Healthcare Administration, or a related field; advanced degree (JD, MBA, MPH, MS, or equivalent) preferred.

  • 12+ years of progressive experience in pharmaceutical, biotechnology, medical device, or healthcare compliance, including experience supporting commercial organizations.

  • Demonstrated success building, standing up, or significantly enhancing enterprise compliance programs within a growing clinical-stage to commercial-stage biotechnology organization.

  • Strong knowledge of healthcare compliance laws and regulations, including FDA promotional requirements, Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, PhRMA Code, HIPAA, and other applicable regulatory requirements.

  • Proven ability to influence stakeholders while driving strategic compliance initiatives across the organization.

  • Exceptional program and project management skills with demonstrated success leading complex, cross-functional initiatives involving multiple stakeholders, competing priorities, and evolving business requirements.

  • Experience developing and executing multi-year compliance roadmaps, implementation plans, governance structures, and organizational change initiatives to support commercial readiness and business growth.

  • Demonstrated ability to prioritize, manage, and execute multiple strategic initiatives simultaneously while meeting aggressive timelines and delivering measurable business outcomes.

  • Experience establishing project governance, defining milestones, tracking deliverables, identifying risks and dependencies, and providing executive-level status reporting and communications.

  • Strong organizational and operational leadership skills with the ability to translate strategic objectives into executable plans, allocate resources effectively, and drive accountability across cross-functional teams. The National salary range for this position is $265K to $285K USD annually. The San Francisco bay area salary range for this position is $275K-$295K 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, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan.

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