Kyverna Deutschlandweit vor 2 Wochen

Sr. Director, Corporate Compliance

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Join us at the forefront of cell therapy innovation and help redefinewhat'spossible.

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Serving as a key member of the Legal leadership team, this role partners with executive leaders and cross-functional stakeholders to integrate compliance intothecorporate strategy and business operations, proactively manage regulatory and ethical risk, and build the foundation for a high-performing Compliance function as the organization growsand transition into commercial stage. • 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 objectivesand commercial-readiness milestones. • Lead the day-to-day operations of the Compliance function,establishingscalable 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 proactivelyidentifyingcompliance risks, regulatory trends, and opportunities thatimpactbusiness 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 escale 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 whileremainingactively 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. • Bachelor's degree in Business, Life Sciences, Healthcare Administration,ora relatedfield; advanced degree (JD, MBA, MPH, MS, or equivalent) preferred. • 12+ years of progressive experience in pharmaceutical, biotechnology, medical device, or healthcare compliance, includingexperiencesupporting commercial organizations. • Demonstrated success building, standing up, or significantly enhancing enterprise compliance programs within a growing clinical-stage tocommercial-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 influencestakeholders while driving strategic compliance initiatives across the organization. • Exceptional program and project management skills withdemonstratedsuccess 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. • Experienceestablishingproject governance, defining milestones, tracking deliverables,identifyingrisks and dependencies, and providing executive-level status reporting and communications. • Strong organizational and operational leadership skills with the ability to translate strategicobjectivesinto executable plans,allocateresources effectively, and drive accountability across cross-functional teams.

This position is also eligible for bonus, benefits, and participation in Company's stock plan. 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. Title: Sr.

Director, Corporate Compliance Reports to: Chief Legal and Compliance Officer Location: Emeryville, CA (Hybrid) or west coast remote TheSr. Director, CorporateComplianceis responsible fordeveloping and leading the company's enterprise compliance program as the organization transitions from clinicalto commercialstage.

This roleestablishesthe 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, theSr.Director, CorporateComplianceprovides enterprise-wide compliance leadership whileremainingactively engaged in building and executing the program. 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.

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