Julie Ebert

Responsible for Building the PM corporate Function

Leader of multiple cross functional Drug Development projects

Management of IT infrastructure

• Worked well in a team setting, providing support and guidance.
• Excellent communication skills, both verbal and written.
• Proven ability to learn quickly and adapt to new situations.
• Skilled at working independently and collaboratively in a team environment.
• Worked effectively in fast-paced environments

• As a member of the R&D leadership team built and led the project management team to manage high quality global development programs in various stages of development. Facilitates executive updates on development programs.
• Oversight of R&D budget process. Development and management C-suite presentation material, long-range planning, and R&D IT infrastructure needs
• Provides oversight for the participation and evaluation of development strategy planning and feasibility.
• Program Management lead for 1 Phase 2 program, 1 Pediatric Program and 2 Phase 3 development programs, sub-teams and filing teams; NDA submission for vibegron (GEMTESA) December 2019-approval December 2020.
• Alliance Manager for collaborations with IQVIA, Merck, Kyorin Holdings and Sumitomo Pharma China. Gatekeeper for all communication of R&D analytics and reporting to parent company Sumitovant Biopharm.
• Represent R&D in all corporate related initiatives and global operating model development to include newly formed Swiss entity.
• Manager of two project managers and one business analyst

• Led R&D Development projects in the therapeutic area of neurology. Program Management of 2 Phase 3 program and multiple phase 2 and post market studies.
• Introduction of project management tools, tracking and standards and organizational structure to move R&D to work in a new manor.
• Working directly with the CMO development of project team structure, roles and responsibilities and executive governance. Included monthly reporting and quarterly development review meetings.
• Development of project gating process
• Training of all R&D employees on process, team structure and governance expectations
• Manager of one project manager

• Worked well in a team setting, providing support and guidance.

• Administration of the Global Project Management system supporting the R&D portfolio
• Usability/leveraging the system.
• Facilitated R&D project team members' ability to gain financing for their projects by ensuring that they fully leveraged the R&D Portfolio Management System's functionality and used it correctly to safeguard accuracy of data.
• Designed and developed all training materials (instructor-led and 24/7 online help training)
• Delivered training on how to use both the system and e-learning to team members (1000+ users) and during new hire onboarding process.
• Management of Global development projects for the Biologics, Consumer Eye Care and Glaucoma therapeutic areas. Therapeutic area PM lead for Consumer Eye Care in multiple phases of development
• Led research teams focused on chemistry, manufacturing and control, technical operations, clinical, commercial research, and development. In some instances, efforts led to products being put on the market. (OPTIVE Fusion, Refresh Tears UD)
• Conducted NPV analysis and justification for options into the portfolio, oversaw budgets ranging from $15-$64MM
• Preparing, tracking, controlling the project (scope, budget, timelines, forecast)
• Co-developed R&D wide integrated system to track project milestones, individual performance, and provide performance ratings for performance reviews.
• Provided project status updates to executive management (EVP, Head of R&D, Chief Medical Officer and Chief Scientific Officer)
• Conducted project management for data analysis and quality control (QC), for senior management initiatives, contributing to the Department's compliance with all World-Wide QA (WWQA) standards for medical device development.

• Representative on Global Development Project teams, CMC Sub teams and Product Validation teams initiated by Allergan Therapeutics, Eye Care/Eye Drops, OTC, Dermatology, Pain and Neurology, Product Enhancements and European research and development groups.
• Planned, prioritized, and monitored all investigational study supply projects for Phase 1, 2 and 3 clinical trials, including manpower, procurement, associated outside costs and timelines.
• Coordinated all contract manufacturing activities (selection, qualification and material movement management for investigational supply efforts, agreements, purchase orders, cost analysis and tracking of drug supply.
• Alliance manager for vendor management within Pharmaceutical Science Operations
• Ensured efficient and timely execution of project requisitions and communication of technical requirements and project status by designing, developing, and monitoring systems supporting these activities.
• Contributed to improvement of PSO processes with use of new computer systems as member of the e- Clinical and IVR/IWR development teams.