Associate Director, Clinical Operations- Biomarker & Bioanalytical Operations

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
 

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Biomarker & Bioanalytical Operations (BBOPs) is a subgroup within the Clinical Operations function. BBOPs plays a key role in ensuring biomarker, bioanalytical and virology research strategy for Gilead clinical trials across all therapeutic areas is executed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports clinical study endpoints.

Associate Director, Biomarker and Bioanalytical Operations leads a team of direct and/or indirect reports. Acts as a leader of managers and individual contributors with a People First approach focusing on employee engagement, development and team health. Lead the operational strategy and oversee execution of biomarker and bioanalytical deliverables across complex studies and/or multiple studies within a program or multiple programs with quality, including financial responsibility. Actively contributes to and may represent BBOPs on strategy teams (e.g. Biomarker Sub teams) as applicable, including providing input and support to Directors as needed. Responsible for the resource management of multiple studies within a program or multiple programs, including ongoing assessment of resource needs and optimal deployment of resources. Leads and/or effectively engage in Clinical Operations, cross-functional and/or country or regional organizational change initiatives and strategy. Drive process innovation and act as Business Process owner for BBOPs processes and/or serves as a SME.

This role partners closely with Clinical Operations Study Teams, Clinical Data Management, Research Biomarker Teams, Bioanalytical Chemistry, Clinical Pharmacology, Clinical Development, and external lab vendors to ensure high-quality sample management, data integrity, and regulatory compliance. The ideal candidate will drive process innovation and clarity to enhance end to end sample management workflows from collection to final disposition.  

EXAMPLE RESPONSIBILITIES:

• Proactively identifies potential operational challenges and provides resolution plans to ensure the biomarker and bioanalytical strategy remains on track; manage multiple programs simultaneously and efficiently.

• Participates in and/or leads departmental or interdepartmental strategic initiatives, including contribution to the development of new systems and processes that help improve department/company performance.
• Drive initiatives to improve sample inventory tracking, ensuring accuracy, visibility, and operational efficiency.
• Lead efforts to streamline the review of long-term sample storage and implement effective sample disposition processes.
• Develop and implement efficient processes for consent codification, ensuring alignment with regulatory and ethical standards.
• Identify and execute improvements in end-to-end sample management workflows, from collection to final disposition.
• As assigned, initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training.
• Work with cross functional teams including internal and external partners to ensure inspection readiness and support regulatory audits as needed
• Serve as a vendor issue escalation point of contact for studies, accountable to ensure issue resolution and mitigations and support vendor governance programs.
• Responsible for forecasting biomarker and bioanalytical budget for clinical studies.
• Manages a team of direct reports and/or indirect reports. Hires, develops and retain