Associate Director, Risk Based Quality Management (RBQM)

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.

Responsibilities

• 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

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

Skills / Competencies

Knowledge & Other Requirements

The salary range for this position is : Bay Area : $195,670.00 - $253,220.00. Other US Locations : $177,905.00 - $230,230.00. 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.