Sr. Director, Corporate Compliance
KyvernaAbout the role
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.
- 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-
Lead the development and ongoing effectiveness of the company's compliance program by:
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