Carlson Project Management Consulting provides expert consulting to the biopharmaceuticals industry in the areas of program/project management, change management, project and resource management systems, and drug development operations analysis and design. Additional details can be found at www.carlsonpmconsulting.com.

• Successfully led a project to upgrade of Alexion’s SharePoint and Project Server 2013 systems into Project Online.• Developed and maintained a set of project plans for one of Alexion’s Phase 3 programs, including creating a detailed submission plan.• Provided project management leadership to a project that successfully implemented a new project time tracking system across all of R&D.• Provided key input to a project to implement a resource modeling capability at Alexion through the design and software selection phases.

Lead a group of 6-8 Project Planners who maintain drug development and submission schedules to corporate standards in support drug development teams. In addition, I co-lead a team that is responsible for establishing standards and business processes associated with project planning, resource management, and portfolio reporting at Pfizer. Beyond my line management responsibilities, I have provided program or project management leadership on the following corporate-wide change initiatives:• Improvements in the tools and processes used to support Pfizer’s regulatory submission process.• Implementing a new project planning and resource management system for the drug development part of Pfizer.• Implementing new tools and processes to support sophisticated scenario planning capabilities within Pfizer’s project planning tools.• Improvements to the quality processes associated with Pfizer’s clinical trials and submissions.

Provided project management leadership to a team that was responsible for a Phase 3 compound. Responsibilities included:• Leading operational planning/execution, risk and mitigation planning and driving decisions.• Leading the operational planning of the team’s accelerated start of a Phase 3 program.In addition, provided project management leadership to a team that was responsible for a portfolio of early development compounds in the neuroscience therapeutic area.

NY-site lead for the Project Planning and Performance function. In this role, I:• Implemented project planning and metrics systems.• Led a group that provided Contracts and Outsourcing support for all four sites that was responsible for negotiating contracts of over $100M annually.

Responsible for the departmental budget, operating plan, resource management, and metrics processes and systems.

Led the technical component of the department’s data management function, a group that supported outsourcing, and a training function.

Responsible for the department’s clinical data management, statistical programming, and safety reporting functions. Led a large staff of 75+ FTEs to accomplish these functions.

Responsible for the development and maintenance of drug safety and reporting systems.

Responsible for the development and maintenance of drug safety and reporting systems.

Provided statistical programming and data management support for multiple drug projects, including leading the programming and data management for a NDA.

Programmed tables and listings to support NDA submissions.