Cambridge, Massachusetts, United States
Business leader with proven record of accomplishment in leading digital and data transformation focused on customer centricity, operational excellence and guiding culture change through innovation. Passionate about the opportunity to have an impact on patient care and healthcare delivery through data, digital and new technologies. 20+ years of experience in business and strategic planning, operations, process engineering, technology solutions delivery and building high performing teams. Proven knowledge of drug research and development processes joined with expertise in strategic and tactical analysis, technology platforms, solution delivery, system support, resourcing models, budget forecasting models, Data Sciences, clinical data management and reporting, clinical data standards, clinical trial operations, outsourcing, system validation and risk management, data strategy and governance.
As a Chief Data officer of R&D (Global Head of RD Data Office), responsible for next generation data strategy development and execution to accelerate the data usage across R&D functions • Build data team and data services portfolio to generate value across functions • Develop data governance program to establish data as an asset, define standards, inventory of data assets and systems • Lead the technology transformation in building strong data foundation layer, data transformation and data management • Define the data strategy and framework for data democratization; policies, business processes for the integrated data sharing and re-use of the data • Collaborate with ITS in building the infrastructure for high computing environments (tools & platforms) which enables data science to accelerate innovation, transformation and impact • Lead the cultural change across organization and strengthen the internal data communities
Lead Central operational services to drive process, data, measurement centricity using centralized capabilities across line functions in Global Development operations. Data Strategy and Data Governance: Build new capabilities in data governance to implement rationalized data flows, metadata management, integration architecture and data quality frame work Data sciences - Strengthening business decisions using predictive analytics, Real world data analytics, Competitive Intelligence analysis, Market Insights. Data enrichment from multiple data sources, metrics development (Metrics, KPIs, KQIs) for senior Leadership team and line functions to assess the operations from cost, time and quality perspectives. Technology services - Lead Clinical Systems ownership, change management, systems portfolio management. Implementation of new processes, digital tool implementation and new integrations for enterprise level systems in Global Development Operations.
Led trial forecast management function to maximize investment decisions and productivity -Accountable for ensuring accurate operational planning and resources of clinical studies portfolio in a timely and compliant way in support of Global Medical Affairs, Translational Clinical Oncology (Over 200 trials and $300M annually) and in collaboration with Global, Regional and Country organizations. Led the strategy and implementation of system landscape to deliver insights to the business to support key portfolio investment and operation decisions. Digitized the forecasting of clinical trial budgets to improve accuracy and deliver insights for rapid informed decisions across the trial life cycle
Lead global technical operation teams comprising of Clinical Database Development, Data Standards, Vendor Data Processing, Data Transformations and Technical Operations to drive operational and business excellence in support of the Novartis Development portfolio. Manage, develop and lead team of functional leads to drive strategy and operational delivery of clinical projects across multiple therapeutic areas. Lead projects across functions in the area of business transformation, process redesign & implementation, and technology selection &implementation in the development organization.
• Led the major innovation projects and process improvements to re-engineer the Scientific imaging systems and system integrations resulted in the automation of data flows • Managed an organization accountable for R&D data supply chain (acquisition, conformance, integration and insights), analytic platforms and data architecture. • Initiated and managed major upgrade of clinical systems to accelerate operational efficiencies; migration took less than 3 months, typically takes 6-12 months; recognized by Oracle as one of the fastest upgrade projects • Led the data governance and analytics organization which is responsible to develop the operational reports, metrics, KPIs and benchmarks • Enhanced strategic relationships with major sponsor/clients through outward facing role as leader of data management and clinical technology operations
• Harmonized the data foundation systems, processes and data governance led to the reduction of data availability timelines from capture to analysis by 25% • Implemented self-service data analytics platforms • Responsible for building the development team, hiring of developers, data engineers and DBAs • Represented organization during audits; lead internal efforts to improve computer system validation and study validation practices through risk-based analysis • Standardized the clinical study development processes that lead to increase in the quality of clinical databases
• Led the technology strategy and implemented electronic data capturing systems to eliminate paper processes which resulted in the reduction of number of queries and increase in operational efficiency by 30% • Oversee the compliance of systems w/ GCP, FDA & ICH regulations (sp. 21CFR11) and data privacy • Developed the migration plan and successfully migrated 39 clinical protocols from existing in-house system to new technology platform
• Played a key role in the implementation of eSubmission system, which supports the submission of clinical studies to regulatory agencies. • Led operations team to deliver eSubmission across therapeutic areas and successfully completed over 25 submissions and NDA, IND, BLA, ANDA and EDC trails eSubmission processes