Associate Director, Compliance (Hybrid, Remote Or On-Site Options)

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 a Associate Director, Compliance to join our Legal Affairs & Compliance team.  This new position will have primary responsibilities pertaining to compliance with healthcare fraud, waste & abuse laws as applicable to clinical laboratory services.  As part of the compliance team, the individual will be responsible for  providing day to day guidance on compliance related matters pertaining to the promotion and sale of medical services to health care customers, drafting policies, assisting with training, audits and monitoring compliance with policies.

What we are looking for:

Experience in a healthcare organization providing review legal advise on interactions 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
• Experience with reimbursement and payer issues is a big plus
• Experience drafting services agreements including laboratory services, phlebotomy agreements, professional services contracts with healthcare providers highly desired
• Ability to identify areas of weakness and deploying risk mitigation strategies
• Self starter with a drive to understand intent of applicable laws in evaluating particular scenarios and providing counsel to stake holders
• Critical thinker with a pragmatic, non-alarmist approach to issue spotting and problem solving

 

Essential Duties and Responsibilities:

• Partner with cross-functional stake holders within the Oncology Division and collaborate with internal compliance team members to identify emerging risk areas for the Oncology Division through awareness of current product specific risk areas and industry compliance trends and challenges
• Provide specialized legal counsel and strategic advice on a wide range of compliance issues to support the development and commercialization of clinical testing services
• 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 to ensure that business programs are aligned with regulatory requirements and industry standards
• Provide guidance with an eye towards problem solving to business partners and key stake holders 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
• Advise 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, Commercial Legal & Chief Compliance Officer

Qualifications

• J.D. with a minimum of 8 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
• Experience drafting, reviewing and negotiating commercial payor agreements, laboratory services agreements, phlebotomy services agreements, professional services agreements with health care providers
• 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 (GDPR, HIPAA, APPI and others) a plus

Work Environment:

Employee may be required to lift routine office supplies and use office equipment.  Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment.  Ability to sit for extended periods of time.

Additional Information

Hybrid Work Model: At Guardant Health, we have 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.

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $151,200 to $205,000 . The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to Peopleteam@guardanthealth.com

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.
To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

Please visit our career page at: http://www.guardanthealth.com/jobs/

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