Senior Manager, Compliance Monitoring

Description

 

Senior Manager, Compliance Monitoring

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 of Compliance Monitoring to assist in enhancing and operating Gilead’s healthcare compliance monitoring program. The location of this role will be based out of the Stockley Park, London office.

Essential Duties and Job Functions

This individual will support the Global Compliance Monitoring Director to lead effective monitoring and oversight of company business activities in compliance with relevant laws, regulations, and policies. Such monitoring and oversight activity will include leveraging of data analytics, risk-based sampling, support of potential investigations and complaints, and assessing observations of various activities & events to identify potential areas of focus. 

The individual will work closely with colleagues within the Legal and Compliance organizations and 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 addressing of potential compliance-related issues. Additionally, the role will work closely with the affiliates and the local legal teams across the organization to support the monitoring program.

A key goal of this position is to help drive innovation and consistency in our approach to compliance-related monitoring outside the U.S. to ensure both Gilead and industry best practices are shared and adopted across geographies and functions.

Key responsibilities also include the following:

Support the Global Compliance Monitoring Director in partnering with colleagues across Legal and Compliance, including affiliate Legal teams and various business functions to develop and align on a multi-faceted monitoring strategy by using outlets such as data analytics, robotics, and artificial intelligence from relevant systems & platforms, live observation of various activities and events, and other risk-based strategies.  Drive the timely development and propagation of ongoing enhancements to the company’s healthcare compliance monitoring program, which shall be informed by an annual risk assessment. Ensuring the carrying out of the global monitoring plan with special focus on areas of historic risk, data anomalies, complaints, and other priorities raised by leadership, as well as tracking and reporting timely remediation as applicable. Execute monitoring from end-to-end, including the ability to independently plan, execute, and report on monitoring activities. This will comprise of creating comprehensive project plans that define objectives, scope, and methodologies, as well as developing interview guides and monitoring checklists to ensure alignment with relevant policies, risk assessment results, and other compliance and business factors. Collaborate with other various business functions to ensure timely and appropriate action is taken to address potential risks and issues identified through periodic risk assessments and compliance monitoring.  Collaborate with the Compliance Analytics and Systems team as well as the Transparency team and IT to support the evolution of the company’s compliance-related systems for improved data capture, automation, data analytics, robotics and artificial intelligence algorithms important to monitoring compliant business activity. Perform data monitoring, identifying trends and potential compliance issues through various methods such as live and process monitoring, and effectively communicating preliminary observations. Additionally, generate detailed monitoring reports that document objectives, approaches, observations, and recommendations, and clearly presenting these monitoring results to leadership and key stakeholders. Partner with various business functions to explore ways in which monitoring-related data may be used to support business strategy and objectives in a compliant manner. Partner with various business functions and compliance colleagues to understand new and emerging business trends for collaborative design of monitoring plans.  Support various business functions in designing business-led monitoring approaches of both higher risk activities and third parties. Use broad strategic thinking to analyze the characteristics of the legal, enforcement, and business environment, and identify methods of adapting monitoring to meet those characteristics. 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 U.S.-based headquarters. The candidate must have a strong background and exposure to compliance-related monitoring and auditing, compliance-related systems, with experience in change management to support effective enhancement of Gilead operations.

Detailed requirements include:

4-5+ years of relevant prior pharmaceutical or biotechnology industry experience, including 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 or prior monitoring experience 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 structures and concepts that facilitate an efficient and effective compliance program. Experience with conducting healthcare compliance monitoring and implementing a monitoring program. 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 monitoring checklists that capture key controls which 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 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) Excellent interpersonal and influencing skills, an inquisitive mind, and the ability to work effectively in a global, matrixed organisation 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 gravitas to work with senior leaders and able to establish rapport with key stakeholders. Ability to quickly establish credibility with diverse audiences and be perceived as an empowering leader yet be hands-on when necessary. Consistently retains a sense of the ‘bigger picture.’

Personal Competencies/ Behaviours

The ideal candidate will be solutions- and results-orientated and will display personal and professional maturity. Additionally, this candidate will display 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)

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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