Associate Director, Risk Based Quality Management (RBQM)

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
 

Associate Director, Risk Based Quality Management (RBQM)

Global Development | Clinical Operations

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.   

Residing within Clinical Operations, Risk Based Quality Management (RBQM) Strategy & Operations is responsible for implementing RBQM in support of the Gilead portfolio.

The Associate Director, RBQM is responsible for timely and high-quality risk-based quality management activities.  Reporting to the Head of RBQM, this role contributes to the development, usage, and health of the central monitoring capabilities and leads study teams in implementing RBQM principles.   

RESPONSIBILITIES:

Study Risk Assessment and Central Monitoring

• Provide expert guidance, training, and support on RBQM in clinical trials, ensuring adherence to ICH GCPs, regulatory requirements, and internal processes.

• Advise study teams throughout risk management activities, fostering cross-functional collaboration, and promoting excellence in risk management. 

• Contribute to the development of new central monitoring tools to address risks and support study oversight.

• Contribute to the identification and definition of Quality Tolerance Limits, risks, thresholds, mitigations, and performance indicators.

• Participate in determining monitoring strategies and mitigation plans aligned with study and site risks, including authoring the Central Monitoring Plan.

• Facilitate cross-functional risk review meetings with study teams, collaborating in risk signal interpretation and triage, ensuring effective communication and resolution of issues.

• Oversee timely resolution of risk signals and issues identified through central monitoring, ensuring appropriate escalation and documentation.

• Support the development and implementation of data analytical tools used for central monitoring.

• Provide technical expertise to set up and test study-level central monitoring analytics.

• Map, manage, and design RBQM data flows to integrate with other relevant clinical and operational databases at study, program, and enterprise level.

• Review central monitoring analytics and assist with the investigation of signals and actions, including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions.

• Identify and interpret anomalies and monitor trends indicative of systematic errors and potential study, site, country, and/or study issues.

• Oversee timely resolution of risk signals and issues identified through central monitoring, ensuring appropriate escalation and documentation.

Operational Excellence

• Serve as a Subject Matter Expert and Process Owner for assigned areas, processes, and technologies.

• Contribute to the development, enhancement, and implementation of RBQM processes, systems, templates, tools, and training materials to support operational efficiency and scalability.

• Manage RACT libraries, driving consistency across programs and therapeutic areas.

• Lead or actively contribute to cross-functional committees, projects and workstreams focused on continuous improvement and innovation. 

• Develop and analyze RBQM performance metrics to assess compliance, effectiveness, and areas for optimization.

• Serve as a champion for change initiatives by fostering an innovative mindset, bridging RBQM knowledge across functions, and promoting new ideas, best practices, and modern ways of working.

• Build and maintain strong partnerships with service providers, influencing strategic relationships and ensuring high-quality deliverables.

• Represent Gilead in industry-wide collaborations, contributing thought leadership and sharing best practices.

• Stay current with RBQM-related regulations, trends, and industry standards to continuously improve the RBQM framework, processes, technologies, oversight, and compliance.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• Bachelor’s degree with 10 or more years of clinical research experience in the biotech or pharmaceutical industry (e.g., clinical development, site management, site monitoring, clinical operations, or data management) OR

• Master’s degree with 8 or more years of clinical research experience OR

• PhD and 5 or more years of clinical research experience required

• Minimum of 3 years of experience in RBQM and central monitoring

• Minimum of 2 years of experience as a Data Scientist, Clinical Research Associate, or Study Coordinator

Skills/Competencies

• Expertise in RBQM strategies, processes, tools, and implementation

• Expertise in the use of data analytic software, Analytical Data Visualization Tools, and MS Excel

• Proficient in R programming language

• Technical understanding of statistical analysis techniques in central monitoring

• Advanced analytical and problem-solving skills; highly attentive to detail and skilled in data analytics

• Ability to lead without authority and influence stakeholders across functions, cultures, and geographies

• Negotiation and conflict resolution skills

• Strong verbal, written, and presentation communication skills

• Fluent in English, both written and spoken

• Strong interpersonal skills and able to build and maintain strong relationships

• Strong cross-cultural competency and global collaboration experience across multiple functional areas

• Ability to quickly absorb study design and therapeutic area knowledge; think critically to identify risks, interpret data trends, and manage issues

• Strong organizational and time management skills; able to work independently, manage competing priorities, and deliver results on time and within budget

• Stay current with RBQM-related regulations, trends, and industry standards to continuously improve the RBQM framework, processes, technologies, oversight, and compliance.

Knowledge & Other Requirements

• Thorough knowledge of national and global regulations and guidelines governing clinical research

• Deep understanding of Phase I-IV clinical studies, clinical operations, and the roles of cross-functional study team members

• Advanced expertise in RBQM, including risk-based monitoring, central monitoring methodologies, quality-by-design principles, risk and issue management, and root causes analyses

• Outstanding knowledge of RBQM-related IT systems and data flows across clinical and operational applications and databases

• High aptitude for data analytics and a deep understanding of statistical concepts

• Ability to travel as needed

The salary range for this position is:

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday.