Director, Screening Compliance

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. 

Position Summary:

Experience in a healthcare organization providing legal advice on contractual arrangements with referral sources for designated health services (DHS).  Specific prior experience in the development/deployment of compliance programs, including all seven elements of the OIG recommended program for clinical laboratories.  The successful candidate will have:

• Extensive knowledge of federal and state laws (False claims act, Starks Law, EKRA, Antikickback statute, anti-bribery and corruption) and industry requirements for the diagnostics/device laws and experience implementing suitable policies tailored for compliance with these laws
• Solid understanding of industry best practices for ethics and compliance risk within the healthcare diagnostics industry
• Proven track record in driving awareness and deploying risk mitigation strategies

Essential Duties and Responsibilities:

• Provide specialized legal counsel and strategic advice on a wide range of compliance issues to support the development and commercialization of cancer screening test products
• Developing a keen awareness of risks associated with the marketing and sale of cancer diagnostic products to proactively address issues and identify opportunities for process improvements
• Provide guidance with an eye towards problem-solving to business partners and key stakeholders through all stages of the product life cycle
• Draft, implement and maintain relevant policies, procedures, work instructions, and training plans related to risk areas
• Maintain current and accurate knowledge of existing and emerging trends, enforcement actions, industry best practices and laws and regulations regarding healthcare compliance and interactions with healthcare professionals
• Advice on legal issues throughout the medical device lifecycle related to clinical research, market access and reimbursement, product launches, commercialization, advertising and promotion, social media, patient access and financial assistance programs
• Review promotional and educational materials as part of a cross-functional team
• Perform routine teaching audits of high-risk functional areas to assess and improve training effectiveness
• Assist with internal investigations, as required, to promote a culture of zero tolerance for non-compliance, with heightened focus on timely follow up on incoming inquiries and complaints
• Manage the lifecycle of corrective actions and remediation plans that address compliance-related deficiencies in processes, procedures, and other operational activities
• Assist with special projects and follow up, as needed, under the direction of the SVP Legal Affairs & Chief Compliance Officer

Requirements

• J.D. with a minimum of 7 years of progressively responsible experience in a legal department of a healthcare organization and/or law firm setting
• Certification in Healthcare Fraud & Abuse Law Compliance preferred
• Working knowledge of clinical laboratory, diagnostic, and medical device industries and designated health services and enforcement of associated federal and state regulations
• Strong research, analytical and problem-solving skills
• Knowledge of Medicare, Medicaid requirements, medical necessity and coding rules and guidelines preferred
• Demonstrated ability to advise and collaborate with business leaders and key stakeholders on compliance issues, facilitating risk assessment and developing practical business solutions
• Training and presentation experience in various settings including live audience and video conferencing
• Excellent strategic and analytical skills with the ability to help business partners identify compliant solutions to novel issues
• Ability to articulate risk without being an “alarmist”
• Excellent verbal and written communication skills
• Knowledge of privacy laws (federal and state laws) a plus

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies.  Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.