Director, Screening Compliance

Guardant Health

11d • Hybrid

About The Position

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. The successful candidate will 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. This role involves 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. Guidance will be provided with an eye towards problem-solving to business partners and key stakeholders through all stages of the product life cycle. The role also includes drafting, implementing, and maintaining relevant policies, procedures, work instructions, and training plans related to risk areas, and maintaining current knowledge of existing and emerging trends, enforcement actions, industry best practices, and laws and regulations regarding healthcare compliance and interactions with healthcare professionals. Advice will be given 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. The role also involves reviewing promotional and educational materials as part of a cross-functional team, performing routine teaching audits of high-risk functional areas, assisting with internal investigations, and managing the lifecycle of corrective actions and remediation plans. The Director will also 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
• 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
• 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

Nice To Haves

• Certification in Healthcare Fraud & Abuse Law Compliance preferred
• Knowledge of privacy laws (federal and state laws) a plus

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

Benefits

• 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 [email protected]
• A background screening including criminal history is required for this role.
• GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).
• 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.
• If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
• Our Work Experience is the combination of everything that's unique about us: our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people. Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the #1 Top Workplace in the area.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree