Clinical Trials Manager- Late Phase Oncology (United States - California - Foster City)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.

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.  

This role will be based out of our Foster City, California or Parsippany, NJ location.

Job   Summary :  

We are seeking a Clinical Trials Manager  (CTM)  to support the   O ncology   pipeline.   The CTM   d rives end-to-end operational delivery of   Phase II and III   oncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight.   This role serves as a key   contributor for study execution and study management   by   coordinating   with the   internal teams and external partners (including CROs and vendors ), and   ensuring alignment across all stakeholders to achieve study   objectives . The CTM applies strong project management, clinical, and regulatory   expertise   to proactively   identify   risks, implement solutions, and   maintain s   study   timelines to meet the study deliverables   for   the   in-house and/or hybrid model clinical trials.  

Prior Oncology   experience and prior CRO/Pharma/Biotech experience   is   required .  

Job Description/  Key responsibilities:  

• Coordinat ing   and supervising all aspects of   clinical   study.  

• Assists Clinical Program Manager in   the   overall 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 and   participate   in selection of CROs/vendors.  

• May m anage CROs/vendors   or functional service providers .  

• May s erve 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 /vendors   are 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   in   determining   the activities to support a project's priorities within   functional   area.  

• Develop tools and processes that   optimize   project   efficiencies   and effectiveness.  

• Travel is   required .  

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

• 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 to   generally 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 management   expertise .  

• Under general supervision,   is   able to   examine funct]]>