Job Description

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.