
Associate Director of Clinical Trial Planning, Resource Management
United States – Remote, United States - California - Santa MonicaClinical Development & Clinical OperationsRegularJob Description
The Associate Director of Clinical Trial Planning, Resource Management, and Reporting is a member of the Portfolio, Project Management and Business Operations team within Development.
The role is accountable for clinical trial planning activities 1.) accuracy of the critical path timelines for multiple studies within a product and accurate representation of the development deliverables including clinical trial demand and strategic study milestone reporting. 2.) facilitating scenario planning in Planisware to support decision making during portfolio prioritization and budget planning. 3.) collaborating with cross-functional development project teams and organization. Resource management and reporting activities 1.) maintaining accurate resource capacity and demand forecasting data in Planisware 2.) coordinating resource inputs for departmental planning and cross-functional project team meetings. 3.) monitoring data quality within Kite systems, dashboards and reports used for portfolio planning and resource forecasting. The position will report to the Director of Business Strategy & Operations.
Responsibilities include but are not limited to:
Clinical Trial Planning:
- Create and maintain detailed clinical trial project timelines, study startup schedules, and scenario-based planning models in Planisware.
- Partnering closely with Project Managers to ensure clinical trial plans have accurate information and milestones, deliverables, and dependencies are aligned across study teams.
- Maintain Kite’s planning environment.
- ensure alignment of standardized project milestone activities across asset, product, and clinical plans
- update project templates and styles.
Resource Management & Reporting:
- Support Director of Business Strategy & Operations, extracting and analyzing resource data provided to Kite leadership and project teams
- Review demand forecasts with cross-functional teams and project managers to gather accurate demand inputs
- Ensure all data remains consistent and standardized for accurate reporting.
- Accountable for maintaining centralized Sharepoint sites, team mailboxes, and Planisware related training documents
- Participate in user acceptance testing (UAT) for Planisware releases and provide training for current and new Planisware users.
- Act as the point of contact for planning and resource reporting tool related issues, updates, and enhancements.
Basic Qualifications:
- A BS/BA degree in nursing, science or health related field required with 10+ years’ experience in pharmaceutical drug development OR
- A MS/MA degree in nursing, science or health related field required with 8+ years’ experience in pharmaceutical drug development OR
- A Ph.D. degree in nursing, science or health related field required with 2+ years’ experience in pharmaceutical drug development OR
Preferred Qualifications:
- Highly experienced in clinical trial plan management and scenario planning using Planisware -8+ years of experience using Planisware for clinical trial planning and scenario planning, and 5+ years of experience in resource management and reporting
- Cross-functional resource allocation and demand forecasting
- Portfolio and resource capacity and demand reporting
- Stakeholder communication
- Risk assessment & mitigation
- Utilization of project management core principles (PMP certification a plus)
- Deep knowledge of the end-to-end pharmaceutical R&D process, including preclinical through post-marketing. (Cell therapy/Oncology preferred)
- Capable of assessing and updating detailed project timelines in meetings to guide and align study team members
- Adept at optimizing resource utilization, driving operational efficiencies, and aligning strategic priorities with project execution.
- Experience supporting cross-functional resource demand with the ability to consolidate, translate and provide resource analyses and portfolio data to leadership and project teams
- Ability to prioritize and execute tasks both as an individual contributor and in a team-based setting
- Strong analytical and problem-solving skills with the ability to multi-task, prioritize, and work on several complex projects while exercising critical thinking with minimal supervision
- Excellent interpersonal, verbal, and written communication, and organizational skills are essential in this collaborative work environment
- Demonstrates leadership skills, self-motivated, and comfortable in a fast-paced dynamic company environment with the ability to adjust workload based upon changing priorities
- Strong computer skills, proficient using MS Office suite (outlook, word, excel, power point, teams), Sharepoint and other organization tools
- Technical experience using Planisware, OnePager, Spotfire, Tableau, Power Bi and/or other business intelligence tools