Responsible for delivery and ongoing support of all IT solutions supporting Commercial and Medical Affairs organizations.• New Franchise / Product (Re)Launch – Leading IT effort to support creation of new Rare Disease franchise and transition/relaunch of Crysvita (an estimated $1B+ annual revenue product) including field force enablement; integration of legacy data; introduction of specialized apps into existing Commercial IT landscape; support for new Marketing campaigns; etc.•… Show more Responsible for delivery and ongoing support of all IT solutions supporting Commercial and Medical Affairs organizations.• New Franchise / Product (Re)Launch – Leading IT effort to support creation of new Rare Disease franchise and transition/relaunch of Crysvita (an estimated $1B+ annual revenue product) including field force enablement; integration of legacy data; introduction of specialized apps into existing Commercial IT landscape; support for new Marketing campaigns; etc.• Technology Roadmaps - Developed and executing upon Commercial and Medical Affairs technology roadmap.• Commercial Data Lake – Implementation of new Commercial Data Lake allowing for advanced analytics, more comprehensive sales/operational reporting and KPIs… and future self-serve reporting & analytics capabilities.• Commercial IT Platform – Renegotiated support contract with MSP for support/maintenance of Commercial IT platform resulting in yearly savings of $600K; standardized metadata tagging of digital assets allowing for faster implementation and better website analytics; introduced demand management, SLAs, SDLC/good development and testing practices resulting in less production errors/rework without reducing time-to-market.• Patient Services – Implemented a feature-rich Patient Services platform to allowing Case Managers to provide unparalleled support Oncology and Rare Disease patients and caregivers.• Medical Affairs Global Business Platform – Leading the effort to implement a global, integrated platform for Medical Affairs… including a global CRM, Medical Information, Medical/Scientific Material Review and Publications Management systems; process redesign; integrated support models; data management and reporting.• KOL Identification & Management – Replacement of current KOL Management solution with more advanced, integrated global system. Show less

Managed Clinical Systems Interdependency effort related to BMS-Celgene merger.• Worked with business and IT to identify, investigate, categorize and prioritize all system interdependencies including those to systems outside of Clinical organization.• Managed and tracked progress related to interdependency and migration efforts.

Responsible for architectural design/development of new integrated eCOA/Big Data platform. • Authored responses to RFIs/RFPs• Provided pre-sales technical support, integration design proposals and high-level implementation approach and estimates

Led Development Information Strategy (DIS) program for Astellas – an “info-centric” transformation of current systems / platforms, processes and operating model. • Worked across Business and IT to create 3-year IT Roadmap and IM foundation• Authored DIS Business Case documenting high ROI and significant efficiency gains for both Business and IT to secure program funding for key program initiatives• Developed current and future-state Capability Model highlighting… Show more Led Development Information Strategy (DIS) program for Astellas – an “info-centric” transformation of current systems / platforms, processes and operating model. • Worked across Business and IT to create 3-year IT Roadmap and IM foundation• Authored DIS Business Case documenting high ROI and significant efficiency gains for both Business and IT to secure program funding for key program initiatives• Developed current and future-state Capability Model highlighting operational performance enhancements and technology opportunities to address the critical business needs• Led creation of new IT Operating Model designed to increase efficiency and better support realization of global strategy Show less

Led client engagements across Clinical, Regulatory & Safety/Pharmacovigilance at Allergan, Novartis and Bristol-Myers Squibb. Responsibilities included:• Business Architecture – effectively applied existing and new technology to cost-effectively address customers key business priorities and concerns• Business Case Preparation – created comprehensive, fact-based business cases highlighting attainable, realistic ROI and true business value to secure funding and senior executive… Show more Led client engagements across Clinical, Regulatory & Safety/Pharmacovigilance at Allergan, Novartis and Bristol-Myers Squibb. Responsibilities included:• Business Architecture – effectively applied existing and new technology to cost-effectively address customers key business priorities and concerns• Business Case Preparation – created comprehensive, fact-based business cases highlighting attainable, realistic ROI and true business value to secure funding and senior executive support• Product / Platform Recommendations – worked across both industry and enterprise to identify best-fit strategic partners• Application Rationalization – identified duplicative systems and processes as the result of mergers, acquisitions and reorgs; developed and executed rationalization plans resulting in significant customer savings • Program Execution – led multi-functional global teams to deliver on key strategic objectives Show less

Assigned by and directly reporting to the VP of MRL IT, instituted a comprehensive program of effective vendor management. Implemented “Voice of Customer” program. Worked across divisions to net new synergies resulting in over $85M in savings in software and services across Merck. Socialized MRL IT Roadmap across all of Procurement to ensure key programs prioritized. Other responsibilities included:• Vendor Identification & Vetting• RFI/RFP Management• Contract… Show more Assigned by and directly reporting to the VP of MRL IT, instituted a comprehensive program of effective vendor management. Implemented “Voice of Customer” program. Worked across divisions to net new synergies resulting in over $85M in savings in software and services across Merck. Socialized MRL IT Roadmap across all of Procurement to ensure key programs prioritized. Other responsibilities included:• Vendor Identification & Vetting• RFI/RFP Management• Contract Negotiations• Vendor Management Show less

Led the Global Submission Management Program - an 18-month, cross-functional post-merger initiative that resulted in the deployment of a single, globally-accessible document repository for all submission-related content.• Migrated over 4 million documents from more than a dozen legacy source systems• Harmonized of submission content authoring, review and approval processes across diverse functional areas such as Clinical, Pre-Clinical, Safety, Labeling, CMC, etc.• Developed and… Show more Led the Global Submission Management Program - an 18-month, cross-functional post-merger initiative that resulted in the deployment of a single, globally-accessible document repository for all submission-related content.• Migrated over 4 million documents from more than a dozen legacy source systems• Harmonized of submission content authoring, review and approval processes across diverse functional areas such as Clinical, Pre-Clinical, Safety, Labeling, CMC, etc.• Developed and executed Change Management plan to aid in adoption of new system and processes by more than 7,800 new users• Integrated new Submission Management system other enterprise systems such as Publishing, Registration Management, Commitment Tracking, Submission Archive and the Reference Data Repository• Upgraded technology platform to support significantly larger user base and document volume• Managed team of more than 30 Business & Technical Analysts and $40M budget• Served as Business Architect determining how to best apply new technology to key Regulatory business functions Show less

Responsible for operation & enhancement of wide variety of systems including those supporting Merck’s investigator-initiated studies program, internal & external publication tracking & indexing, the Merck Manual and internal audits/inspections tracking. Highlights include:• Working closely with business community, created the first multi-year strategic roadmap for CMO and capability model• Identified synergies across seemingly disparate organization resulting in cost-savings from… Show more Responsible for operation & enhancement of wide variety of systems including those supporting Merck’s investigator-initiated studies program, internal & external publication tracking & indexing, the Merck Manual and internal audits/inspections tracking. Highlights include:• Working closely with business community, created the first multi-year strategic roadmap for CMO and capability model• Identified synergies across seemingly disparate organization resulting in cost-savings from shared technologies / platforms• Led the SaaS (Software as a Service) evaluation & selection process to replace several aging, custom-built applications• Oversaw technology stack refresh of Merck Manual platform (Professional, Home and Veterinarian) • Served as Tech Lead on several CMO initiatives including cross-company Real Work Evidence project and Key Opinion Leader Database implementation Show less

Served as the Technical Lead on integration of Schering-Plough’s and Organon BioScience’s Pharmacovigilance systems.• Supported migration of all Organon adverse event (AE) data into Schering-Plough’s AE reporting system• Developed and tested system redundancy, database backup & recovery strategy• Re-architected reporting system to handle 40% larger data volume and increased number of report requests• Partnered with software vendor to identify and resolve system bottlenecks… Show more Served as the Technical Lead on integration of Schering-Plough’s and Organon BioScience’s Pharmacovigilance systems.• Supported migration of all Organon adverse event (AE) data into Schering-Plough’s AE reporting system• Developed and tested system redundancy, database backup & recovery strategy• Re-architected reporting system to handle 40% larger data volume and increased number of report requests• Partnered with software vendor to identify and resolve system bottlenecks and implement multiple performance enhancements Show less

Newly-created position responsible for end-to-end oversight of all Clinical Systems – documenting data flows, lineage and usage to provide a comprehensive understanding of all the data collected and how it’s used.Led the integration of Schering-Plough’s and Organon BioScience’s Clinical Research systems.• Project encompassed more than 40 systems and 2200+ new colleagues• Managed all aspects of project – from network resource integration to account requisition to user… Show more Newly-created position responsible for end-to-end oversight of all Clinical Systems – documenting data flows, lineage and usage to provide a comprehensive understanding of all the data collected and how it’s used.Led the integration of Schering-Plough’s and Organon BioScience’s Clinical Research systems.• Project encompassed more than 40 systems and 2200+ new colleagues• Managed all aspects of project – from network resource integration to account requisition to user training • Developed plan to support 77 new trials without increase in IT staff and/or significant system changes• Developed migration/retirement strategies for Organon’s Trial & Data Management systems• Evaluated the impact of supporting new therapy areas using existing systemsLed Global Clinical Systems Integration effort – developed new/streamlined existing interfaces to support 30% increase in trial volume without impacting performance of systems. Responsible for technology alignment across Global Clinical Systems as well as alignment with Schering-Plough’s Corporate Technology Roadmap. Show less

Managed Schering-Plough's Trial Management system – a custom-built, feature-rich application used by more than 1400 people in over 40 countries.• Managed team of 20 on-shore/off-shore business analysts, programmers and DBAs• Led effort to outsource maintenance and support of application - the first GxP system at Schering-Plough to be outsourcedLed New Clinical Trial Management System (CTMS) Selection project.• Managed RFP process - developed objective, weighted… Show more Managed Schering-Plough's Trial Management system – a custom-built, feature-rich application used by more than 1400 people in over 40 countries.• Managed team of 20 on-shore/off-shore business analysts, programmers and DBAs• Led effort to outsource maintenance and support of application - the first GxP system at Schering-Plough to be outsourcedLed New Clinical Trial Management System (CTMS) Selection project.• Managed RFP process - developed objective, weighted scoring criteria to evaluate products and vendors; managed product evaluation and selection processes; managed evaluation and selection of Siebel integratorsServed as Global Clinical System’s IT Lead on Drug Delivery Improvement project. Show less