Associate Director, Risk Based Quality Management (RBQM)

Role Summary

Associate Director, Risk Based Quality Management (RBQM) within Global Development | Clinical Operations. Responsible for timely and high-quality risk-based quality management activities, contributing to the development, usage, and health of central monitoring capabilities, and leading 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

Minimum Education & Experience

• Bachelor‚Äôs degree with 10+ years of clinical research experience in biotech or pharmaceutical industry OR
• Master‚Äôs degree with 8+ years of clinical research experience OR
• PhD with 5+ years of clinical research experience
• 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
• Experience with 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; attention to detail and data analytics
• Ability to lead without authority and influence across functions, cultures, and geographies
• Negotiation and conflict resolution skills
• Strong verbal, written, and presentation communication skills
• Fluent in English
• Strong interpersonal and cross-cultural collaboration abilities
• Ability to absorb study design and therapeutic area knowledge; think critically to identify risks and interpret data trends
• Strong organizational and time management skills; able to work independently and manage competing priorities
• Stay current with RBQM regulations, trends, and industry standards

Education

• As listed in Minimum Education & Experience

Additional Requirements

• Ability to travel as needed