Clinical Trials Manager- Late Phase Oncology

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, andwe’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.  

JobSummary:We are seeking a Clinical Trials Manager (CTM) to support theOncology pipeline.The CTM drives end-to-end operational delivery ofPhase II and IIIoncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight.This role serves as a keycontributor for study execution and study managementbycoordinatingwith theinternal teams and external partners (including CROs and vendors), and ensuring alignment across all stakeholders to achieve studyobjectives. The CTM applies strong project management, clinical, and regulatoryexpertise to proactivelyidentify risks, implement solutions, andmaintains studytimelines to meet the study deliverables for the in-house and/or hybrid model clinical trials.  

Prior Oncologyexperience and prior CRO/Pharma/Biotech experienceisrequired.  

Job Description/Key responsibilities: 

• Coordinating and supervising all aspects ofclinical study.  

• Assists Clinical Program Manager intheoverall study management. 

• Provide input into study protocols,investigator brochures,case report forms, and informed consents, final study reports, oversee/author study plans, and presentations. 

• Maintains study timelines.including documentation and communications. 

• Contributes to development of study budget. 

• Contributes to development of RFPs andparticipate in selection of CROs/vendors. 

• May manage CROs/vendors or functional service providers. 

• May serve as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to conducting oversight monitoring visits. 

• Provide oversight of study sites/region and review routine regulatory documents to ensure that CROs /vendorsare in compliance with protocols, regulatory requirements, SOPs, and monitoring plans. 

• Ensures effectiveness of site budget/contract process. 

• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements. 

• Coordinates review of data listings and preparation of interim/final clinical study reports and appendices,including resolving any data discrepancies. 

• Assists indetermining the activities to support a project’s priorities withinfunctional area. 

• Develop tools and processes thatoptimize projectefficiencies and effectiveness. 

• Travel isrequired. 

• Excellent teamwork, communication, decision-making and organizational skills arerequired. 

• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable. 

• Must be able togenerally understand, interpret, and explain protocol requirements to others. 

• Must be able to prioritize multiple tasks. 

• May serve as a resource for others within the company for clinical trials managementexpertise. 

• Under general supervision,is able to examine functional issues from an organizational perspective. 

• Must havegeneral, functionalexpertise to support SOP development and implementation. 

Basicqualifications: 

• 5+ Years with BS/BAin a relevant scientific discipline. 

• 3+ Years with MS/MA in a relevant scientific discipline. 

People Leader Accountabilities:  

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.  

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receiving the feedback and insight needed to grow,develop and realize their purpose.  

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.