Kite Pharma · 2 weeks ago
Senior Clinical Trial Manager - Late Phase
Santa Monica, CA
Full-time
Onsite
Mid, Senior Level
$143K/yr - $185K/yr
4+ years expKite Pharma, a Gilead Company, is dedicated to curing cancer through innovative therapies. They are seeking a Senior Clinical Trial Manager to oversee global Late Phase studies, ensuring compliance with regulatory guidelines and the timely delivery of high-quality clinical data.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
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
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
Qualification
Required
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
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
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
Preferred
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
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Kite Pharma
Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.
1001-5000 employees
H1B Sponsorship
Kite Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (47)
2023 (54)
2022 (59)
2021 (53)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$335.38MKey Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO
Leadership Team
Mark Jurgens
Vice President, Global Head of Evidence Generation & Strategic Collaborations
Craig Vermeyen
Director, Packaging and Labeling
Recent News
BioWorld Financial Watch
2025-12-29
2025-12-07
Company data provided by crunchbase