Associate Director, Healthcare Compliance (Screening)

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

Guardant Health has an exciting new opportunity for an Associate Director, Healthcare Compliance, to join our Commercial Legal & Compliance team to support our new Screening Division.  This new position will have dual responsibilities serving as a legal counsel overseeing day-to-day contract matters and as a compliance advisor to stakeholders within the Screening Division.   The position will work closely with the Chief Compliance Officer, the Privacy Officer, and a lean compliance team in ensuring compliance with all applicable legal and regulatory requirements for the promotion and sale of medical services to primary care practices.

What we are looking for:

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
• Experience drafting, reviewing and negotiating commercial payor agreements, laboratory services agreements, phlebotomy services agreements, clinical trial agreements, and professional services agreements with health care providers
• 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
• Review, revise and negotiate commercial contracts, laboratory services agreements and other business agreements
• 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 VP, Commercial Legal & Chief Compliance Officer

Qualifications

• J.D. with a minimum of 5 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 laborato