Sr. Clinical Trials Manager, Clinical Operations- Oncology

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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
 

Gilead has a rich pipeline of promising medicines across multiple indications in Oncology with numerous submissions and readouts planned through 2025 and beyond.  There are >15 active pivotal registrational trials, a robust early-mid phase pipeline, and a myriad of partnerships, collaborations, and opt-ins that require strong Clinical Operations leadership of study management teams and global oversight of trial activities including site and contract resource operations (CRO) partnerships.

Specific Responsibilities and Skills:

• Has advanced knowledge of study management best practices and tools and has shown ability to apply these to improve project efficiencies and effectiveness.
• Has significant industry (ICH/GCP and FDA/EMA regulations) knowledge, including knowledge of drug development, and is able to flex own knowledge to work on studies of varying scope and complexity.
• Contributes review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
• Independently creates and manages budgets and resource plans for assigned studies and other work, seeking advice as needed.
• Responsible for identifying cross-study synergies to leverage efficiencies and ensure consistencies where appropriate.
• Leads moderately complex assignments that enable multiple functions and teams to achieve their clinical study objectives within targeted timelines and allocated resource levels.
• Collaborates with other functions on how to best achieve their clinical goals and objectives.
• Drives accountability and oversight of CRO to ensure the overall program(s) is completed compliantly, on-time, within-budget and to the quality expected.  
• Consistently models our Leadership Commitments and Values for others to follow.
• Has the managerial courage to speak-up when needed, and in a manner that moves the business and team forward.
• Gives constructive, fair, balanced, concise and actionable feedback.
• Takes accountability to ensure change is understood and implemented well.
• Effectively influences without authority.
• Ensure study delivery is on time, as per scope and compliance, and within the allocated budget
• Demonstrates ability to think short- and long-term in devising appropriate project strategies and approaches to completing project deliverables.
• Coaches and guides less experienced team members in solving problems. Depending on business need, may manage Clinical Project Assistant/Clinical Trial Management Assistant/Sr. Clinical Trial Management Assistant

Knowledge

• Working knowledge and experience with Word, PowerP