Sr. Director, Corporate Compliance
New
K
Kyverna TherapeuticsBiotechnology
Emeryville, CA (Hybrid) or west coast remoteFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 12+ years
- Required Skills
- Project ManagementHIPAA
Requirements
- Bachelor's degree in Business, Life Sciences, Healthcare Administration, or a related field (Advanced degree preferred).
- 12+ years of progressive experience in pharmaceutical, biotechnology, medical device, or healthcare compliance.
- Experience supporting commercial organizations.
- Demonstrated success building or enhancing enterprise compliance programs in a clinical-to-commercial stage organization.
- Strong knowledge of healthcare laws and regulations, including FDA promotional requirements, Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, PhRMA Code, and HIPAA.
- Exceptional program and project management skills.
- Experience developing and executing multi-year compliance roadmaps and governance structures.
- Proven ability to influence stakeholders and drive strategic cross-functional initiatives.
- Demonstrated ability to manage multiple strategic initiatives simultaneously.
- Strong organizational and operational leadership skills.
Responsibilities
- Serve as the program manager for enterprise compliance buildout and commercialization-readiness initiatives.
- Develop and execute the enterprise compliance program strategy and roadmap.
- Lead day-to-day operations of the Compliance function, including governance, policies, and systems.
- Partner with executive leadership and cross-functional teams to integrate compliance into corporate strategy.
- Provide guidance on healthcare compliance risks related to commercialization and interactions with healthcare professionals.
- Establish risk-based third-party compliance diligence, onboarding, and monitoring processes.
- Measure program effectiveness through metrics and periodic assessments.
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