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1110 Kite Pharma, Inc.
Senior Manager, External Research Program (ERP)
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What they do
A Clinical Research Manager is responsible for managing the day-to-day research operations of an organization undertaking clinical trials, usually pharmacological drug testing.
$171,043 / year median in California
Job Description
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 Kite's External Research Program (ERP) advances our enterprise portfolio through external innovation and data generation. This role will manage operations and track progress for investigator-sponsored and collaborative studies across our evolving portfolio. Key Responsibilities Manage day-to-day administration and operations for ISRs and clinical collaborative studies from concept approval to study closure: Plan the external project timeline and regularly monitor adherence, metrics, and progress throughout the study lifecycle Partner with global, regional, and local Medical Affairs teams, Translational Medicine, Safety to review protocols and research plans Work with Kite & Gilead partners to carry out budget analyses, regulatory submission support and contract negotiations Support clinical demand accuracy, clinical logistics preparation and Tech Ops readiness efforts by tracking institutional start up activities and ensuring timely progress Work with institutional contacts to reliably maintain study data in iEnvision platform to ensure single source of truth Monitor study milestones (e.g., deliverables, enrollment status, publications) and process monthly invoicing to support financial forecast accuracy Ensure effective, accurate, and timely communication to meet the needs of internal and external stakeholders Proactively identify gaps in SOP and prepare updates to ERP playbook to address gaps or reflect process improvements and changes Contribute to monthly leadership reports to illustrate the evolving ERP portfolio Communicate frequently with external institutions to assure compliance with research activities and provides direction for those institutions regarding research, contractual, and milestone compliance, recruitment, and reporting Basic Qualifications Master's and 4+ years of experience in the pharmaceutical industry/project management OR Bachelor's with 6+ years of experience in the pharmaceutical industry/project management OR Associate and 8+ years of experience in the pharmaceutical industry/project management OR High School Diploma/GED and 10+ years of experience in the pharmaceutical industry/project management Preferred Qualifications Good understanding/experience in clinical and/or pre-clinical research, or experience in Clinical Research/Development, Medical Affairs Established communication, project management, problem solving, and organizational skills, including management of multiple priorities and resources while maintaining attention to detail Proactive, self-motivated, and resourceful - able to cultivate path forward in ambiguous circumstances and know when to ask for support or escalation PMP or equivalent project management qualification an advantage Experience of working in an international environment and distributed workforce an advantage Affinity for a collaborative, team-oriented environment, and approach; ability to appropriately interact within Global Medical Affairs and across diverse departments, senior management, and external customers/vendors Comfortable synthesizing information to support leadership presentations and memos Knowledge and skill with Smartsheet, Microsoft Excel, Word, PowerPoint, Visio, and other reporting and tracking tools • The salary range for this position is: $153,935.00 - $199,210.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma. For jobs in the