Senior Manager, External Research Program (ERP)

Kite Pharma•Parsippany, NJ

2d•$153,935 - $199,210

About The Position

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.

Requirements

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

Nice To Haves

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

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.