David Simonson Email & Phone Number

Boston, Ma, Us

Worked and Led large scale Pharmaceuticals Commercialization Projects including Process Transfer, Method Transfer, Digital Strategy, Commercial Risk Management, Program Reporting, Site Commercialization, Regulatory Strategy, and Ramp Planning.• Partnered closely with area leads to develop and maintain integrated project plans; including close parternship with CDMO manufacturing partners• Identified and communicated interdependencies as well as critical path activities for all assigned projects• Tracked and monitored key milestones and decision points and work with project team members to meet commitments and drive delivery of project objectives• Effectively communicated with team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects• Organized and maintained team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses/mitigation strategies using preferred technologies• Updated and maintained project status tools, such as a project action log, risk register, dashboards, and after action reviews• Improved and optimize program risk management process• Supported functional areas during long range planning / budget planning• Assisted in the creation and deployment of standards and templates around project and workload management to improve efficiency, expand functional capabilities and streamline use of resources.• Consistently performed duties within established SOPs, and in accordance with GxP requirements, where applicable

Beverly, Massachusetts, Us

Advisory Board Member for the LVO - YMCA in Marblehead, MA, which is part of the YMCA of the North Shore Association.

Seattle, Wa, Us

Engagements Include:Optimization and Deployment Project Lead at pre-clinical phase Gene Therapy organization • Led key stakeholders through a Benchling (Electronic Lab Notebook) optimization engagement• Partnered with Informatics team to build a set of application usage metrics to track Benchling adoption and utilization across the organization and by team/manager• Worked with key stakeholders to set a standard of registration schema usage for proper experiment tracking to ensure all data is captured to support Intellectual Property (IP) legal filings• Help to facilitate and design key processes to configure Benchling to enable proper GLP usage to support documentation needed for filing activities Tech Transfer Project/Program Lead at a Large Pharmaceutical/Life Science Company - Cell Therapy ManufacturingProvided program and project management support to a large, global pharmaceutical company as it built a new Cell Therapy manufacturing facility with a planned capacity of >40 patients per week and a potential revenue of > $1B• Managed Tech Transfer workstream which included QA, QC, Supply Chain, Manufacturing, and MS&T functions to support a new commercial facility build out• Ensured proper tracking and closure of program Risks, Issues, Action, and Decisions and worked with key stakeholders to ensure issues were escalated and mitigated in a timely manner• Supervised and mentored functional project managers that were responsible for supporting the individual functional areas• Led Comp Readiness Team which was responsible for ensuring that functions met all prerequisites of the comparability, process performance qualification protocols, and GMP readiness• Picked to drive operational improvements to material coordinate between site and global supply chain teams to ensure all materials were onsite to support critical milestones• Partnered with new PMO group to develop PMO governance and intake process for all site projects and improvement initiatives

Boston, Massachusetts, Us

Develop and execute global strategy as is relates to Global Services and Global Delivery with a focus on improving the Client Experience through better Inquiry Management, Improved process re-engineering, and advanced client analytics & insights. Provide strategic direction and guidance to project teams to drive optimization activities that add value to the State Street & Client partnership Highlights•Led team of internal consultants and hand-picked to lead the newly formed Productivity Center of Excellence (COE) to deploy a SaaS application to track operational improvement results; program includes significant change management and focuses on providing transparency to team supervisors and managers on how to more efficiency manage the organization, identify process improvement initiatives, and remove business waste. Current projections are to achieve a run rate save of 30MM by end of 2022• Accelerated the internal and external adoption of State Street’s interaction management tool to provide a single point of contact for all clients and to identify internal and client operational pain points and to increase client responsiveness• Generated next level metrics and KPI’s to provide greater insight into how State Streets serves its clients and enable data driven decision making and baseline for continuous improvement• Brought contact center and customer experience ideas and best practices to the interaction management tool to provide a better client experience• Developed and executed on strategy to leverage AI/Machine Learning to auto categorized and auto route client questions; lays the groundwork to auto answer simple/standard questions• Created strategy to review 15,000 reports currently being created across all clients and to either decommission, standardize, automate, or provide self-service solution to; reduce cost/effort required to deliver client reporting

Boston, Ma, Us

Manages a team of data scientists and data engineers (10 direct reports) to support the US Division Insurance and Wealth Management operations and IT groups to develop and execute strategic analytical and optimization projects to reduce operating cost and increase revenues, streamlining business processes and improving the customer journeyHighlights• Built financial models to support key strategic projects to optimize Call Center and Sales Desk operations including replacing current phone system with Amazon Connect • Re-engineer business processes and provide data modeling to Claims Operation teams to reduce expenses and improve the customer experience; reducing expenses by >$1MM/year• Examined and changed Shared Service expense model to more accurately track IT expenses across the business unit and reducing uncategorized expense leakage • Developing model to predict NPS using call center and operational data to drive better decision making; reduce expenses and improve customer experience• Drive operational improvements through Optimization and Decision Analytics • Conducting deep dive financial analysis to discover opportunities to significantly reduce operating and IT spend to save $6M off a $30M base

Boston, Ma, Us

Equipped prospective customers to apply for life insurance without an advisor or sales agent by launching a direct to consumer e-application using Agile framework. Collaborated closely with product owners, business PMs, and a Scrum Master. Cultivated and facilitated communication and problem resolution with the Strategy, Operations, Marketing, IT, and Product teams, capably mediating cost, scope, and scheduling concerns. Highlights:• Led an initiative to define improvements in customer experience and life insurance application processes as part of problem resolution at call centers using Design Thinking. Cut application completion times by initiating productive conversations with the customer and sales agent. Increased the number of signed applications through an effective technical solution. • Directed a data migration project in support of a third-party database reporting tool, strengthening reporting capabilities. • Helped roll out a new customer facing landing page and activated the “web to lead” feature in Salesforce for a life insurance product through back-end development functions. • Orchestrated stakeholder engagement functions as part of accountabilities spanning weekly and monthly progress monitoring and creation of financial reports for review by senior leaders in the U.S. Division.

Boston, Ma, Us

Integration Lead, Guide Financial Acquisition Strategized and executed the GUIDE Financial acquisition integration plan, realizing the benefits of a large company scale while preserving the agility and independence of the acquired setup. Defined schedules for and monitored integration activities, ensuring fulfillment of requirements company-wide, including Information Risk, Legal/Compliance, Global IS, Procurement, Finance, HR, and communications. Highlights• Integrated a startup company into the larger organization by negotiating an exception to company policy to employ a newly formed enterprise infrastructure group in a separate test and experimentation environment. • Established a small stakeholder group comprised of IT, finance, legal, communications, HR, and branding staff to offer quick feedback and guidance as necessary.

Boston, Ma, Us

Project Director Valuation Systems Transformation (VST) Helped advance a $100M project to standardize and strengthen processes critical to the consolidation of all valuation data as the key contact for the U.S. Division and liaison to the Global VST program. Arranged meetings between IT, Information Risk, and the project manager to validate Azure in alignment with security and data governance standards. Migrated and test multiple applications to showcase Azure as a viable infrastructure solution. Highlights• Fulfilled critical milestones for data migration through completion of system extracts, Extract Transform Load (ETL) processes, Data Warehouse loading, and control frameworks. • Managed divisional risk reporting tools and templates, engineering timely and accurate updates for U.S. Division stakeholders. • Cut year-end reporting times by ~4K hours per year, a 65% drop. Directed the QLIKview pilot program, including vendor-led training, management of three small teams of report developers, and updating senior managers on project success. • Detailed division and benefits using a financial model outlining project delivery and projected results. • Overhauled application intake and project initiation processes for the financial group, sharpening cooperation between finance and IT teams and eliminating unauthorized “shadow IT” functions.

Boston, Ma, Us

PM – Global Resourcing Alternate Site Project (2013-2014)• Received Executive Committee GATE III approval on $10M-$15M Alternate Site Project in Q4-2013; Manulife Business Process Services (MBPS) - Cebu started operations on time in August 2014• The Program’s purpose was to develop the Global Resourcing Site Strategy by examining a global list of potential cities for Manulife’s next Global Resourcing Center (GRC), and develop/execute the plan for site execution and commence site operations• Managed two separate vendor engagements to assist in the research and required due-diligence• Conducted weekly working team meetings with members from multiply functions and divisions to deliver project deliverables; Member included representatives from Global Information Services, Global Real Estate, MBPS, Risk, Finance, Operations, IS, HR, US Div, Canadian Div, Asia Div, and Investment Div• Project examined 41 possible locations down to 1 recommendation; presented to the Executive Committee in July 2013Developed first version of Transition Playbook (2012-2013)• The purpose was to assist business units and functions successfully transfer work and roles to Manulife’s Shared Service Centers• Goal was to shorten the time to transition and lessen the productivity dip and transition costsDeveloped first version of Global Resourcing Forecast Template (2012-2013)• The purpose was to add uniformity and structure to the Global Resourcing forecast process• Gathered requirements from the BU’s and from MBPS and created a document that would facilitate the collection and analyzing process

Arlington, Va, Us

Selected for 18 -24 month project, responsible for the PRISM (SAP system for Operations, Quality, and Supply Chain Management) implementation for all of the Raytheon, IDS (Integrated Defense Systems)SAP Implementation Defect Manager (2011-2012) • Handpicked to manage defect tracking process including prioritization and managing work done by 10 process teams to ensure efforts are being focused on the most critical items. Responsible for communicating road blocks to Project Leadership.SAP Implementation Team Member (2010-2011) • Developed functional specifications as required for business functionality. Contributed to new business operating and reporting strategy with focus on leveraging upgraded Enterprise Resource Planning (ERP) program.• Reconciled current business processes with SAP functionality to align with and be prepared for future state processes.

Arlington, Va, Us

Manufacturing Cell Lead (Manufacturing Manager) (2009-2010) • As the supervisor for 20-25 Represented Employees (Union), assigned, prioritized, and followed up on work assignments and aligned resources (equipment and personnel) to ensure customer’s cost, schedule, and quality objectives were met.• Deeply involved in company wide Lean Six Sigma initiatives and continuous improvement projects.

Quincy, Ma, Us

• Managed manufacturing systems involved in producing over $350 million of natural oil products per year.• Supervisor for over 40 technicians responsible for natural oil refining, fatty acid production, and wastewater processing. Participated in annual budget process and maintained cost controls to meet finalized budget.• One of three managers responsible for design, construction, and implementation of $1.2-million-dollar wastewater system.

Washington, Dc, Us

Submarine Learning Center Program/Product Manager (2006-2007) • Effectively coordinated tasking of 90 Action Officers across 14 Submarine Force Mission Areas to ensure quality-training solutions were successfully produced.• Project Manager for Submarine Force Training Scheduling Utilization (TSU) web based program, including collecting feedback from customers, analyzing and translating feedback, and reporting the desire upgrades to developers/programmers.• Primary liaison between major commands for publication, guidance changes and associated required submarine force training• Helped develop and test new training products for use by the entire United States Submarine fleet Nuclear Submarine Junior Officer (Division Officer) (2001-2006) • Progressed through two different division officer positions and one assistant department head position. Direct management of 10-20 people as a division officer (Electrical and Reactor Controls Division) and 50-60 people as the Assistant Weapon's officer.• Shipyard operations - coordinated daily activities of shipyard employees and navy team members in preventive/corrective maintenance, repairs, upgrades, and installations of systems and equipment during a nuclear refueling overhaul• Normal operations - supervised operation of the submarine nuclear propulsion plant

Mba, Business, Corporate Finance

Master Of Science - Ms, Finance, General

Bs, Chemical Engineering