Gilead Sciences, Inc.
Senior Clinical Trial Manager - Late Phase
Gilead Sciences, Inc., Santa Monica, California, United States, 90403
Senior Clinical Trial Manager - Late Phase
United States – California – Santa Monica. Clinical Development & Clinical Operations – Regular
Job Description We are dedicated to curing cancer and advancing personalized CAR T-cell therapies. Join Kite, a Gilead Company, as we shape the future of oncology immunotherapies and expand our global clinical operations team.
The Clinical Operations team executes Phase 1‑4 clinical trials worldwide. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures all trial activities comply with SOPs, company policies, and regulatory guidelines to deliver high‑quality data supporting global registration and commercialization.
Essential Duties and Job Functions
Plan, execute and oversee global and regional Late Phase studies, including Phase IV, non‑interventional, observational, real‑world evidence, registry, and post‑marketing safety/effectiveness studies.
Draft and coordinate review of study documents (protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports).
Develop and maintain study timelines and risk mitigation plans.
Contribute to study budget development and to the creation of RFPs for selecting CROs/vendors.
Provide strategic oversight and guidance for global Late Phase studies; coordinate review of interim/final clinical study reports.
Ensure effectiveness of site budget and contract processes.
Train CROs, vendors, investigators, and study coordinators on study requirements.
Partner with Clinical Program Managers and other functional managers to influence key business decisions.
Specific Responsibilities
Lead operational planning and execution of global/regional Late Phase studies with independent judgment within defined guidelines.
Excel in project management, handling multiple studies and increasing complexity.
Provide guidance and daily oversight to ensure studies stay within program budgets and timelines.
Contribute to the development of abstracts, presentations and manuscripts.
Basic Requirements
Master’s degree and 4+ years of related experience OR Bachelor’s degree and 6+ years of related experience OR High School Diploma and 11+ years of related experience.
Preferred Requirements
Scientific degree or higher, especially in oncology or cell therapy.
Experience managing Late Phase clinical trials.
Experience with monitoring, line management, or working with FDA regulations, GvP, and clinical trial conduct standards.
Strong functional expertise in SOP development, teamwork, decision‑making, communication, and organization.
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.
Salary: $143,225.00 – $185,350.00, with discretionary bonus, stock‑based incentives, paid time off, and a comprehensive benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans.
Equal Employment Opportunity Statement: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants, fostering an inclusive work environment. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity, veteran status, or any other protected characteristic.
#J-18808-Ljbffr
Job Description We are dedicated to curing cancer and advancing personalized CAR T-cell therapies. Join Kite, a Gilead Company, as we shape the future of oncology immunotherapies and expand our global clinical operations team.
The Clinical Operations team executes Phase 1‑4 clinical trials worldwide. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures all trial activities comply with SOPs, company policies, and regulatory guidelines to deliver high‑quality data supporting global registration and commercialization.
Essential Duties and Job Functions
Plan, execute and oversee global and regional Late Phase studies, including Phase IV, non‑interventional, observational, real‑world evidence, registry, and post‑marketing safety/effectiveness studies.
Draft and coordinate review of study documents (protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports).
Develop and maintain study timelines and risk mitigation plans.
Contribute to study budget development and to the creation of RFPs for selecting CROs/vendors.
Provide strategic oversight and guidance for global Late Phase studies; coordinate review of interim/final clinical study reports.
Ensure effectiveness of site budget and contract processes.
Train CROs, vendors, investigators, and study coordinators on study requirements.
Partner with Clinical Program Managers and other functional managers to influence key business decisions.
Specific Responsibilities
Lead operational planning and execution of global/regional Late Phase studies with independent judgment within defined guidelines.
Excel in project management, handling multiple studies and increasing complexity.
Provide guidance and daily oversight to ensure studies stay within program budgets and timelines.
Contribute to the development of abstracts, presentations and manuscripts.
Basic Requirements
Master’s degree and 4+ years of related experience OR Bachelor’s degree and 6+ years of related experience OR High School Diploma and 11+ years of related experience.
Preferred Requirements
Scientific degree or higher, especially in oncology or cell therapy.
Experience managing Late Phase clinical trials.
Experience with monitoring, line management, or working with FDA regulations, GvP, and clinical trial conduct standards.
Strong functional expertise in SOP development, teamwork, decision‑making, communication, and organization.
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.
Salary: $143,225.00 – $185,350.00, with discretionary bonus, stock‑based incentives, paid time off, and a comprehensive benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans.
Equal Employment Opportunity Statement: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants, fostering an inclusive work environment. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity, veteran status, or any other protected characteristic.
#J-18808-Ljbffr