Steve Shimek Email & Phone Number

San Diego County, California, United States

Irvine Ca

Managed the Mergers, Acquisitions, Divestiture, Alliances and Partnerships program as it pertained to Research and Develop Information Technology.▪ Established the solutions strategy for unstructured content transfer for all Mergers, Acquisitions, Product Divestitures, Partnership, and Alliances▪ Transitioned solutions strategies to project portfolios using gap and business case analysisLed transition of asset-related data of 9 return-to-partner products as a part of the AbbVie R&D portfolio revamp▪ Established strategy and led IT programs for divesting 17 products (compounds and medical devices) as it pertains to extracting, transferring and QCing source data related to Intellectual Property, Non-Clinical studies, Clinical studies, Safety/PV, and Regulatory Affairs, while working alongside Business Development and Alliance Management▪ Managed the IT projects that integrated several acquired companies into the Allergen Aesthetics organization▪ Steered the ring-fencing, transfer, and purge of data for numerous divested drug as part of the US Federal Trade Commission (FTC) and EU European Commission (EC) stipulation agreement as part of the approval of AbbVie to acquire Allergen▪ Designed/implemented the harmonized utilization of Microsoft Teams across the entire active Drug and Device Project Pipeline Portfolio (109 assets) to enable collaboration within the various cross-functional teams for managing documents, tasks/action items, risks, decisions, meeting minutes, threaded discussions/chats (with tags), and videoconferencing ▪ Consulted on the rationalization of many legacy Allergen R&D systems, such as QMS, CTMS, TMF, Clinical Supplies, Product Portfolio Mgmt, Regulatory Publishing, Registration Tracking, PV, R&D Procedural Docs, Project Collaboration, etc.▪ Led the consolidation of Veeva Vaults including: Vault QualityDocs, TMF, RIM, Validation, and Platform

Irvine Ca

Managed several key technology initiatives for moving Allergan R&D into a consolidated future state. ▪ Veeva Vault Clinical eTMF (Trial Master File) – Led major project including business case justification, program governance, configuration, testing, validation, change management, training, integrations, etc. This was an extremely aggressive project of 5 months from start to end.▪ Veeva Vault Clinical SSU (Study Start-Up) - Led intensive project including business case justification, program governance, configuration, testing, validation, change management, training, integrations, etc. This project was unplanned and was added in parallel to the eTMF project. The timeline was 6 months with 3-month of overlap with the eTMF project.▪ Box GxP Compliance - Led instrumental project including business case justification, R&D governance formalization, validation, migration protocol establishment, permission management workflow engine replacement integrated with Box via API’s. This solution enabled the use of Box to manage and archive controlled regulated content.▪ TriNetX RWD (Real World Data) – Established the use of 75 million electronic patient medical records, including but not limited to: disease state, medications, laboratory results, medical procedures, vital signs, demographics, genomics, cardiology, pulmonology, oncology, patient location, and mortality. Instituted processes that ensured reduction/elimination of clinical study protocol amendments and improved patient recruitment/on-boarding. Aided in research by comparing cohorts, evaluating/comparing outcomes, and analyzing treatment pathways. Developed on-boarding process, which included account management, training, reference materials, and support channels. Developed a process for synthetic RWD studies and ‘Know Your Patients’ training program.▪ TranCelerate – Key member of the Shared Investigator Platform (SIP), eSuite (CPT, SAP, CSR) and Technical Council Teams

Irvine Ca

Directed the implementation and management of Knowledge Management technologies across 46 pharmaceutical, biotechnology and device companies acquired by Allergan within the last five years. Managed the Information Technology integration of acquired companies and/or intellectual property. Establishing solutions consolidating collaboration environments, positioning cross platform search technologies, harmonizing the use of cloud technologies with over 2100 partnerships within Research & Development. These services cover 14,400+ full time and 9,300+ contingent employee worldwide and are used to discover and develop new and novel therapeutics and devices for patients.As System Owner, extended the following collaboration technologies across R&D:▪ Box – Pioneered the uses of Box in the pharmaceutical industry, developed governance process for using Box for R&D partnerships, spearheaded the decision to use Box in place of Microsoft OneDrive, expanding it into the rest of the Branded organization, and led the effort to migrate 950+ legacy company personal accounts into the Allergan Box instance.▪ RD Search - Negotiated with technology vendor and both Legal Councils to convert our L-AGN contract to a new Allergan 3-year contact and extend our licenses to 12,000 users which ensured a license cost-free deployment to Branded R&D business at $180K per year ($540K total savings). ▪ SharePoint – Led the charge to integrate the numerous SharePoint platforms across the acquisition conglomeration of R&D centers, which included evaluating the best of breed and redirecting the Branded R&D organization, and implementing a cohesive platform across Science Innovation (Biology, Chemistry, New Business), Pharm Sci, NC, Clinical, Reg Affairs, and Med Affairs.

Managed the Information Management (IM) program across Research & Development, Regulatory Affairs and Medical Affairs which includes the following functions: Enterprise Content Management, Corporate Library Sciences, and Records Management.▪ Designed and implemented a fast (Google-like), comprehensive (Kayak-like), and easy-to-use (Amazon-like) search engine for unstructured content internally across all R&D repositories and selected external repositories▪ Established an Enterprise Document Management Virtual COE Governance Module for both controlled and uncontrolled content management solutions which consisted of Best Practices, Training, eLearning (learning bursts), Implementation Services, and Support▪ Developed the Allergan Enterprise Content Management 3-5 Year Strategy and Roadmap and refreshed it every three years▪ Operated as System Owner for all controlled and uncontrolled content management systems (including dozens of integrations) across R&D including FirstDoc TMF/R&D (with SPX and CRX), Documentum eSubmissions and eCTDs, Documentum DCM, SharePoint, Box, Captiva, and fileshares▪ Researched, selected, procured, and implemented a secure cloud-based device-enabled collaboration solution used to manage project documents throughout R&D 400+ partnership which allowed Allergan to become the ‘partner of choice’ by providing a fast easy-to-use authentication independent service ▪ Developed a best-in-class governance module for the use, management, and control of the external partnership content management solution that ensured IP protection▪ Migrated users and documents across 359 project teams from the legacy external partnership solution (SharePoint) onto the new solution (Box)▪ Established a cross-functional Information Management Office with 47 members charted with tackling the most challenging projects related to document/records management such as the centralizing computer system validation deliverables into a single and cohesive repository

▪ Built and managed the Information Management program across Research & Development and Regulatory Affairs ▪ Deployed SharePoint in a way that enabled project and study teams to obtain access and manage relevant specific controlled documents alongside the uncontrolled documents within a single project SharePoint site, which increased efficiency by reducing the need to go outside the single team environment and also reduced training across project/study teams▪ Migrated 154 R&D project teams (transitioned 62 active and retired 92 inactive) and migrated 73 departments from custom Documentum to SharePoint and FirstDocReorganized Corporate Library Service, which reduced the costs (not including subscriptions) by 58% and lowered resources by over 50%▪ Trained people globally (US, Europe, Asia, Australia/NZ, So. America) on Content Management Best-Practices

▪ Managed the configuration and implementation of FirstDoc TMF and FirstDoc R&D, including a harmonized permission model, best-practices, training, and support across R&D▪ As part of internal project management responsibilities, assumed both the CSC Business Analysis and Project Manager roles, reducing the project costs by over $260K ▪ Managed numerous FirstDoc system integration projects to ensure data integrity and elimination of labor costs

Advising on business model and finance opportunities to develop and distribute ARV/HIV, hepatitis, and malaria therapeutics to under-developed countries.

Managed the recruitment of the Director of Enterprise Content Management

Directed the implementation of the first enterprise-wide and largest computer application in Amgen history. Established and managed a Project Management Office (PMO) for the development, deployment and support of Enterprise Document Management (DM) to 20,000+ users worldwide.▪ Administered an annual program budget of $13.8M from client accounts▪ Managed organization of 23 full-time employees and 20-30 contractors/consultants▪ Developed Enterprise Content Management strategies and defined Service Roadmaps in concert with Amgen’s strategic plans, which ensured ECM capabilities were deliveredInstituted an Enterprise Services Governance Council, facilitated sessions, and presented stakeholder operating reviews that resulted in governance for effective decision-making▪ Coordinated the centralization of all DM support, applications, and technologies services, which enabled scalable capabilities to support future company growth▪ Using RUP, established and managed program risks, issues, decisions, and workforce management across all projects, which reduced resource and schedule conflicts▪ Championed organizational change management across the ECM, which resulted in harmonized work processes that enabled workforce leveling of company resources

Thousand Oaks, California, United States

Project managed the development and implementation of a new R&D document management system.▪ Implemented best practices across the value chain, which enabled the harmonization of EDM processes and eliminated several overlapping systems that resulted in the reduction of support costs and increased process efficiencies within clinical development

Managed all information systems within Research and Development including budget and staff. Coordinated the stability program for nutritional supplements, foods, beverages and OTC drugs for a multi-billion dollar international corporation.▪ Managed R&D Information Systems responsible for services, budget and staff▪ Implemented enterprise DM system across two divisions and enterprise LIMS system across 13 laboratories resulting in services that support scalable processes▪ Supervised department responsible for records management and publishing of Regulatory Dossiers, Manufacturing Instructions, Batch Records, and SOPs▪ Conducted regulatory agency inspections ensuring governmental compliance and approval of manufacturing and distribution licenses▪ Overhauled stability program for measuring performance of products resulting in shelf life increases and improved product profitability supporting development of 250+ new products contributing to a 440% revenue increase

Managed numerous departments along the commercialization process within medical device company.▪ Responsible for acquiring manufacturing and distribution licenses from the FDA▪ Assisted in the development of new medical devices based on market demand▪ Managed the software engineering, validation and distribution▪ Develop marketing literature and support documentation creating a easier to use product thus reducing technical support costs by 18%▪ Lead the outsourcing effort which eliminated two production lines and reduced costs by 35% and 27% delays

Managed quality control inspectors, laboratory scientists and associated processes.▪ Partnered with US Dept of Agriculture Meat/Poultry and Egg/Dairy compliance agencies ▪ Developed Statistical Process Control program with increase quality by 11% and decrease rework by 17%▪ Spearheaded Safety Committee creation and implementation

Executive Masters Of Science Degree, Technology Management

Masters Certification, Project Management

Masters Degree, Business Administration

Bachelor Of Science Degree, Computer Science

Bachelor Of Science Degree, Comprehensive Biology