Senior Manager, Healthcare Compliance Risk

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

We are seeking a Senior Manager to assist in enhancing and operating Gilead’s healthcare compliance monitoring, risk assessment, and third-party due diligence programs. The location of this role will be based out of Foster City, California or Parsippany, New Jersey.

Essential Duties and Job Functions

This individual will support the monitoring, risk assessment, and third-party due diligence teams with activities in compliance with relevant laws, regulations, and policies. These activities will include leveraging data analytics, risk-based sampling, leading risk assessment trainings and discussions, supporting potential investigations and complaints, and live observation at various activities and events to identify potential areas of focus.

The individual will work closely with colleagues across different functions, including key partners such as IT, Commercial, Development, Medical Affairs, Public Affairs, Government Affairs, Finance and Clinical, among others, in order to leverage information from relevant systems for identification and address of potential compliance-related issues.

A key goal of this position is to help drive innovation and consistency in our approach to compliance-related monitoring, risk assessment, and due diligence to ensure both Gilead and industry best practices are shared and adopted across functions.

Key responsibilities also include the following:

• Support the team to develop and align on a multi-faceted monitoring and risk assessment strategy.

• Drive the timely development and propagation of ongoing enhancements to the company’s healthcare compliance monitoring and risk assessment program.

• Collaborate with the team to ensure timely and appropriate action is taken to address potential risks and identified issues.

• Partner with various business functions to explore ways in which monitoring and risk assessment related data may be used to support business strategy and objectives in a compliant manner.

• Support various business functions in designing business-led monitoring approaches of both higher risk activities and third parties.

• Responsible for facilitating requests for diligence on new and existing vendors, including communicating with internal colleagues and third parties to gather all required information to complete diligence.

• Conducting review of due diligence questionnaires and external checks to identify potential red flags or areas for further inquiry.

• Serving as a resource and point-of-contact for questions from internal colleagues and third-party representatives going through due diligence.

• Compiling and analyzing reports and metrics and presenting results to colleagues, so that we can continually assess and adjust our risk-based program.

• Foster an energizing work environment where employees have impact on our patient-centric mission and can grow their careers.

Knowledge, Experience and Skills

Gilead is looking for an experienced risk management professional from the biotech and/or pharmaceutical industry. Ideally the successful candidate will have gained exposure to working within a multi-national organization with a US-based headquarters and has relevant experience with regulatory/pharmaceutical compliance and fraud & abuse laws (e.g., Foreign Corrupt Practices Act; UK Anti-Bribery Statute; Anti-Kickback Statute). The candidate must have a strong background and exposure to healthcare compliance-related monitoring and risk assessment, compliance-related systems, with experience in change management to support effective enhancement of Gilead operations.

Education and Skills:

• 7+ years of relevant prior pharmaceutical or biotechnology industry experience, including extensive professional experience advising on anti-kickback/anti-bribery laws and other compliance mandates.

• Bachelor’s degree required. Advanced degree (such as JD/MA/MS/MBA) or other similar certification preferred.

• Project management experience and/or certification preferred (e.g., Project Management Professional).

• Excellent verbal and written communication skills in English.

• Able to exercise judgment and propose courses of action where precedent may not exist.

• In-depth understanding of business objectives and how those translate into healthcare compliance priorities to deliver advice and guidance to the business.

• Experience with conducting healthcare compliance monitoring, risk assessments and third party due diligence.

• Ability to plan a monitoring activity with little to no oversight (e.g. create a project plan that clearly identifies the objective, scope, and monitoring approach; can generate an interview guide that helps facilitate discussions to better understand the risk associated with processes, and create testing sheets that captures key controls which also aligns to the expectations of applicable policies).

• Ability to execute a monitoring activity with little to no oversight (e.g. perform data monitoring and analyze data for unusual trends, outliers, and compliance with applicable policies; perform live monitoring to identify compliance issues through in-person or virtual review of an activity; perform process monitoring to identify compliance issues through documentation review of an activity, and ultimately share and validate preliminary observations with the business).

• Ability to report on a monitoring activity with little to no oversight (e.g. create a monitoring report that clearly documents the objective, approach, observations, recommendations, and clearly present the objective, approach, and results of the monitoring report).

• Ability to present complex information in an accurate and persuasive manner to all levels of management.

• Excellent interpersonal and influencing skills, an inquisitive mind, and the ability to work effectively in a global, matrixed organization with multiple functions, together with a positive attitude and strong work ethic.

• Experience developing and using advanced Excel-based models, data analytic tools (e.g., Alteryx, Tableau) and conducting quantitative analysis.

• Experience, confidence, resilience, and ability to establish rapport with key stakeholders.

Competencies/ Behaviors

The ideal candidate will be solutions- and results-orientated. S/he will display personal and professional maturity and have a strong work ethic and personal integrity.

• Proven leadership skills with an ability to set a vision, inspire, champion change, and drive innovative thinking

• Collaborative, team player that leads by example

• Strong strategic thinking skills with ability to see the big picture, and to formulate and execute strategy

• Excellent influencing, interpersonal and communication skills

• Demonstrated ability to network, engage and partner with other functions, and establish positive relationships

• Strong judgment with proven ability to identify to implement solutions

• Strong organizational and project management skills and ability to execute through others

• Proven analytical skills and sound judgment

• Practical approach to problem-solving

• Consistently demonstrate and adhere to Gilead’s Core Values and create and inspire a team culture committed to the same

Gilead Core Values

• Integrity (always doing the right thing)

• Teamwork (collaborating in good faith)

• Excellence (working at a high level of commitment and capability)

• Accountability (taking personal responsibility)

• Inclusion (encouraging diversity)