Associate Director, Risk Based Quality Management (RBQM)

Gilead Sciences•Foster City, CA

14d

About The Position

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.

Requirements

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
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.
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

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.

Benefits

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.

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