Clinical Trials Manager, Biomarker​/Bioanalytical Operations

Overview

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. 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. 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. 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.

As a Clinical Trials Manager, Biomarker/Bioanalytical Operations
, you will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members. You will manage certain components of clinical studies and act as a member of the study team. You will also manage biomarker and bioanalytical vendors. You will assist in the review of clinical study protocols and other study documents, contribute to process development and/or participate in special projects.

You may also participate in strategic initiatives.

• Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and bioanalytical strategies in Gilead (GS) and Collaborative (CO) programs
• Participate in multiple Phase 1-4 clinical study teams
• Plan and coordinate all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial
• Provide sample management expertise to the Study Management Teams (SMTs), Biomarker Sub Teams (BSTs), and Clinical Pharmacology Subteams (CPST)
• Accountable for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent
• Primary interface for operational activities between the SMT and laboratory vendors; provide day-to-day operational management of vendors to ensure delivery data against contracted scope of work
• Ability to critically evaluate scientific proposals or protocols, and budget for clinical operation feasibility
• Establish strong cross-functional relationships and exhibit leadership with counterparts in other functional teams to ensure efficient execution of the study biomarker strategy
• Proactively identify potential operational challenges and, in collaboration with senior team members, provide resolution plans to keep biomarker strategy on track
• Organize and lead Biomarker and Bioanalytical operational meetings with study functional groups or vendors
• Maintain internal Biomarker and Bioanalytical Operations databases and document repositories
• Review relevant documents including protocols, informed consents, and relevant study documents
• Understand, interpret and explain protocol requirements to others
• Assist in determining activities to support a project’s priorities within the functional area
• Contribute to development of RFPs and participate in selection of CROs/vendors
• Examine functional issues from an organizational perspective
• May contribute or participate in special projects
• Develop tools and processes that optimize project efficiencies and effectiveness
• Participate in the recruiting and hiring…