Director, Screening Compliance

🕒 June 2

🇺🇸 United States – Remote

💵 $217.6k - $299.2k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 45%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Guardant Health

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Guardant Health is a precision oncology company that specializes in using blood tests to revolutionize cancer care. Their innovative tests provide critical insights that help inform treatment decisions for patients across all stages of cancer. By leveraging advanced technology and data, Guardant Health aims to improve clinical outcomes and enhance the overall patient experience in the fight against cancer.

📋 Description

• Provide specialized legal counsel and strategic advice on compliance issues supporting development and commercialization of cancer screening test products • Develop awareness of risks associated with marketing and sale of cancer diagnostic products and identify process improvement opportunities • Guide business partners and key stakeholders through all stages of the product life cycle • Draft, implement, and maintain policies, procedures, work instructions, and training plans related to risk areas • Maintain current knowledge of trends, enforcement actions, industry best practices, laws, and regulations regarding healthcare compliance and healthcare professional interactions • Advise on legal issues throughout the medical device lifecycle, including 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 and timely follow-up on inquiries and complaints • Manage corrective actions and remediation plans addressing compliance-related deficiencies • Assist with special projects and follow-up 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 • Ability to travel, on occasion (~15%) • Experience providing legal advice on contractual arrangements with referral sources for designated health services • Experience developing and deploying compliance programs, including all seven elements of the OIG-recommended program for clinical laboratories • Extensive knowledge of federal and state laws, including False Claims Act, Stark Law, EKRA, Anti-Kickback Statute, and anti-bribery and corruption laws • Experience implementing suitable compliance policies tailored to healthcare diagnostics/device laws and requirements • Solid understanding of ethics and compliance risk best practices within the healthcare diagnostics industry • Proven track record driving awareness and deploying risk mitigation strategies • Availability to work during U.S. Pacific Time zone working hours • Background screening including criminal history required • Ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements

🏖️ Benefits

• Base salary range of $217,600–$299,200 for the primary and other U.S. locations • Colorado base salary range of $230,400–$316,800 • Hybrid work model with designated in-person collaboration days and work-from-home days for eligible onsite employees • Reasonable accommodations for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs