Dir of Compliance

  • 505 Penobscot Dr, Redwood City, CA 94063, USA
  • Full-time

Company Description

Guardant Health is a pioneer in non-invasive cancer diagnostics and the first company to commercialize a comprehensive genomic liquid biopsy. Our proprietary digital sequencing technology is transforming cancer treatment by providing an accurate and precise picture of the individual genomic alterations that cause tumors to grow, change, and develop resistance to treatment. We have combined decades of scientific research, advances in laboratory technology, and our breakthrough innovation in liquid biopsy to create new tests that have already handled tens of thousands of samples. We believe our tests can accelerate new drug development and improve the lives of all patients fighting cancer. Our current products are just the beginning of what we hope to accomplish and new uses of our platform are emerging.

We succeed best by coordinating our creative talents and energies to achieve results far beyond what any single individual could accomplish. We seek very talented people who want to be part of our fantastic team.

Job Description

This position reports directly to the Chief Compliance Officer.  The Dir of Compliance is responsible for the management and execution of the company Compliance Program to oversee HCP interactions and engagements, monitoring practices within the organization, audits and investigations, privacy, transparency and international anti-bribery certification process.

Daily Compliance Activities:

  • Responsible for the development, implementation, and ongoing improvement of the Compliance Program; provide guidance to company personnel on ethics, operational compliance and risk issues.
  • Responsible for building and maintaining effective working relationships with internal and external stakeholders, including consulting with in-house legal staff as necessary to address compliance issues.
  • Liaise with various departments and serve as an expert on compliance knowledge and guidance resource for the Company, providing education and training on fraud and abuse laws, including but not limited to the Stark Law, Anti-Kickback Statute, Federal False Claims Act, global privacy laws and state specific rules and regulations.
  • Collaborate with international business partners and local counsel for adherence to international laws and regulations.
  • Draft and maintain compliance policies and SOPs in accordance with evolving business needs and applicable regulations.
  • Conduct compliance investigations from intake to resolution; collaborate with other functions to provide recommendations.
  • Ensure corrective actions are adequate and are implemented for all identified compliance deficiencies.
  • Develop and conduct educational sessions on various compliance-related topics; draft and implement policies and procedures.

Monitoring, Auditing and Risk Assessment Activities:

  • Review terms for all HCP contracts; audit HCP engagement activities
  • Investigate any reported or other detected compliance issues associated with HCP interactions
  • Perform routine privacy compliance monitoring activities to ensure company wide compliance with HIPAA, GDPR, APPI and other privacy regulations in consultation with the Chief Compliance Officer and Security Officer
  • Lead or support privacy related activities including response to internal/external access, disclosure, and permitted external/internal use of protected personal information
  • Identify suitable third party auditors for internal and external audits (as needed)
  • Be responsible for certain aspects of company wide risk assessment activities

Qualifications

  • Four-year BA/BS degree; JD preferable
  • Certification in healthcare compliance by a national association or similar accredited institution
  • Bachelor’s degree and post graduate degree (preferred); JD or Masters in Healthcare Administration.
  • At least 8 years of specific compliance experience working either in a health care organization Compliance Department or in a related capacity.
  • Working knowledge and understanding of regulations pertaining to Healthcare Compliance (AKS, False Claims, Stark, HIPAA, etc.)
  • Knowledge of international privacy regulations including GDPR
  • Experience in biotech, healthcare or medical device industries is preferred.
  • Experience developing, implementing, and monitoring a compliance program.
  • Experience with metrics used to measure success of the compliance program.
  • Demonstrated experience identifying and resolving compliance issues.
  • Previous global compliance oversight desirable

Core Competencies 

  • Ability to work autonomously with limited direction
  • Ability to maintain confidentiality of sensitive matters
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure timely, on target and within-budget accomplishment of such.
  • Proven track record of effective decision-making: makes good business decisions and consistently exercises sound judgment. Applies sound judgment around escalation of issues.
  • Excellent verbal and written business communication skills; ability to clearly and succinctly articulate position and rationale to others.
  • Strong influencing skills: proven track record and experience building and cultivating relationships with key partners and stakeholders across organizational levels. Ability to manage conflict and negotiate corrective actions with cross-functional stakeholders.

Additional Information

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 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.

 

 

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