Senior Clinical Trials Management Associate

Overview 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 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 Title Senior Clinical Trials Management Associate (in-house sponsor position; some travel required). Responsibilities Oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking of samples, enrollment of study participants, and management of vendors. Apply knowledge of clinical research operations and FDA regulations/ICH guidelines. Report to a Senior Clinical Trials Manager of Clinical Operations. Prepare and/or review study-related or essential start-up documents (e.g., clinical protocols, informed consent forms, investigator brochures, monitoring plans, laboratory manuals, case report forms, and other study plans and charters) as delegated by the study manager. Coordinate with contract research organizations to communicate timelines and ensure obligations and performance expectations are met; provide corrective instruction as needed. Attend internal and external meetings; provide training at investigator meetings and trial-specific meetings (site initiation visits, monthly teleconferences). Create and review site feasibility assessments required for study participation. Manage and track key study deliverables (screening, enrollment, biological samples and images, data flow, protocol deviations). Identify potential study issues/risks and propose/implement solutions; escalate issues to the Senior Manager as appropriate. Prepare metrics and updates to key deliverables for management. Assist in the resolution of clinical trial queries and data review for interim analyses, primary analyses and final database locks. Prepare site newsletters and other correspondence related to clinical trial conduct in collaboration with the study team. Assist in resolution of routine study questions from clinical trial sites, adhering to ICH GCP and the study protocol. May lead less complex studies and/or manage components of more complex studies as a member of the study team. May participate in department initiatives or special projects, such as developing new tools or processes. Coach less experienced colleagues and understand how decisions impact broader study goals. Other duties as assigned. Basic Qualifications BS/BA in nursing, science or health-related field and 4 years of related experience – OR – MS/MA in nursing, science or health-related field and 2 years of related experience. Preferred Qualifications Bachelor’s degree in nursing, science or health-related field with at least five years of related experience. Oncology/hematology or related therapeutic area experience is a plus. Experience managing external candidates; ability to travel at least 25% (possibly more). Strong time management, analytical, problem-solving, attention to detail, organizational, and communication skills. Ability to work in a fast-paced, small company environment with minimal direction and adaptable to changing priorities. Working knowledge of transplant patient care and apheresis collection is a plus. Salary and Benefits The salary range for this position is: Other US Locations: $115,260.00 – $149,160.00. Bay Area: $126,820.00 – $164,120.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary by role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. Equal Opportunity Kite Pharma is an equal employment opportunity employer. We are committed to fostering an inclusive work environment for diverse perspectives, backgrounds, and experiences. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or protected characteristics, or other non-job related criteria in accordance with applicable laws. #J-18808-Ljbffr