Senior Clinical Trial Manager - Late Phase

Kite Pharma • Santa Monica, CA

22d

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. Job Description 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.

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
• 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
• 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)

Nice To Haves

• 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

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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees