Senior Clinical Trial Manager - Late Phase

Descripción del trabajo

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening
diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation.

Kite, a Gilead Company, is a biopharmaceutical company that is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.
We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every-day discoveries that include our own capabilities and our individual potential.

The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialization of Gilead’s products.

An exciting and challenging opportunity has arisen to join the Clinical Operations team based in Santa Monica as a Senior Clinical Trial Manager, specializing in Late Phase studies.

Essential Duties and Job Functions:

• Responsible for the planning, execution, and oversight of global and regional Late Phase studies, including Phase IV, non-interventional, observational, real-world evidence (RWE), registry, and post-marketing safety/effectiveness studies.
  Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
  • Develop and Maintains study timelines and risk mitigation plans.
  • Contributes to development of study budget.
  • Contributes to development of RFPs and participates in selection of CROs/vendors.
• Provides strategic oversight and guidance for global late phase studies
  • Coordinates review of interim/final clinical study reports.
  • Ensures effectiveness of site budget/contract processes
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
  • Assists in determining the activities to support a project’s priorities within functional area.
• Partners with Clinical Program Managers and Managers in other functions, providing input where key decisions impacting business operations will be made.

Specific Responsibilities:
Works with Clinical Program Managers to lead operational planning and execution of global/regional late phase studies with latitude for independent judgment and decision-making within defined guidelines.

• Excels in project management and demonstrates ability to take on more studies and/or studies of greater complexity Understands how the design and operations of late phase studies impact the goals of various functions.

In partnership with CPMs, provides guidance and daily oversight for the successful
management of all aspects of late phase studies within designated program budgets and timelines.
• Contributes to development of abstracts, presentations and manuscripts.

Basic Requirements:

• Masters and 4+ years of related experience OR
• Bachelors and 6+ years of related experience OR
• High School Diploma and 11+ years of related experience

Preferred Requirements:
• Educated to degree level or above within a scientific discipline
• Oncology and Cell Therapy/ATIMP experience is desirable

• Previous study management experience at trial management level, preferably in a late phase setting
• Previous monitoring experience is desired but not essential for the role
• Line management is desired but not essential
• Thorough knowledge and understanding of FDA Regulations, GvP and clinical trial conduct standards
• experience, interpreting, and explaining protocol requirements to others

•Excellent functional expertise to support SOP development and implementation
• Excellent teamwork, decision-making, communication and organizational skills

Gilead & Kite Core Values
• Integrity (always doing the right thing)
• Teamwork (collaborating in good faith)
• Excellence (working at a high level of commitment and capability)
• Accountability (taking personal responsibility)
• Inclusion (encouraging diversity)