Sr. Healthcare Compliance Lead

The Sr. Healthcare Compliance Lead plays a critical leadership role in supporting and advancing CareDx's healthcare compliance program. This role is responsible for ensuring that all business activities-particularly those involving interactions with healthcare professionals, patients, and third-party vendors-are conducted ethically and in full alignment with applicable laws, regulations, and internal standards.

This individual will serve as a trusted advisor and strategic partner to business functions across the organization, helping to proactively identify risks, implement effective controls, and foster a strong culture of compliance.

Key Responsibilities:

• Enhance and Operationalize the Compliance Program: Support the ongoing development, implementation, and refinement of CareDx's Healthcare Compliance Program to ensure effectiveness and relevance as the company grows.
• Cross-Functional Compliance Partnership: Act as a compliance liaison and advisor to business units, while ensuring business strategies, initiatives, and daily operations comply with healthcare regulations and corporate policies.
• Risk Monitoring & Mitigation: Identify and assess compliance risks across key business functions. Collaborate with internal stakeholders to develop and implement mitigation strategies and operational controls.
• Training and Education: Develop and deliver engaging, role-specific compliance training programs for employees and contractors. Provide clear, practical guidance on healthcare compliance expectations and best practices.
• Third-Party Oversight: Manage compliance diligence and monitoring processes for vendors, consultants, distributors, and other third parties. Ensure that appropriate risk assessments and contractual safeguards are in place.
• Audits and Escalations: Support internal compliance audits and ensure suspected violations are escalated. Lead and ensure remediation plans and correction plans are appropriately documented
• Policy Management: Revise, and maintain internal compliance policies, SOPs, and related documentation. Ensure policies reflect evolving regulations and industry best practices.
• Other responsibilities: Perform additional compliance-related tasks and projects as needed to support the evolving needs of the organization.

Qualifications:

• Bachelor's degree required, advanced degree highly desirable
• Minimum of 7+ years of experience in a healthcare compliance role, within the pharmaceutical, biotech, diagnostics, or medical device industry.
• Strong working knowledge of U.S. healthcare laws and regulations, including but not limited to: Anti-Kickback Statute (AKS), False Claims Act (FCA), Stark, HIPAA, and FDA
• Proven ability to partner effectively across functional teams and influence stakeholders at all levels.
• Exceptional communication, analytical, and project management skills.
• Demonstrated integrity, judgment, and ability to handle sensitive and confidential matters with discretion.