Clinical Trials Manager, Biomarker/Bioanalytical Operations

Responsibilities

• Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation ofbiomarker and bioanalytical strategies in Gilead (GS) and Collaborative (CO) programs
• Participate in multiple Phase 1-4 clinical study teams
• Plans and coordinates all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial
• Provides sample management expertise to the Study Management Teams (SMTs), Biomarker SubTeams (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; Provides the day-to-day operational management of vendors to ensure delivery data against contracted scope of work
• Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility
• Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., Biomarker
• Sciences, Vendor Outsourcing, Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker strategy.
• Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure biomarker strategy remains on track
• Organizes and leads Biomarker and Bioanalytical operational meetings with study functional groups or vendors
• Maintains internal Biomarker and Bioanalytical Operations databases and document repositories
• Review of relevant documents including protocols, informed consents, and relevant study documents
• Must be able to understand, interpret and explain protocol requirements to others
• Assists in determining the activities to support a project's priorities within functional area
• Contributes to development of RFPs and participates in selection of CROs/vendors
• Able to examine functional issues from an organizational perspective
• May contribute or participate in special projects.
• Develops tools and processes that optimize project efficiencies and effectiveness.
• Participate

Benefits

Additional Information

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 At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. 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

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