Led creation and execution of a new complex function to drive collaboration across 3DS brands for co-development of products. Leveraged existing technology and cross-domain expertise to solve new business problems and grow 3DS product portfolio. Managed matrixed team of 20+ targeting $100M+ revenue potential. Investment postponed due to geo-economic climate. Leveraged business and clinical expertise working in partnership with other domains (manufacturing, laboratory, 3D simulation, engineering) to identify and develop opportunities for protocol digitization, trial supply management, and patient engagement in healthcare applications. Retooled and successfully launched new generation of low code application platform (LCAP) purpose-built for rapid development of life sciences and patient-centric healthcare applications on state-of-the-art clinical software platform to unlock new software revenue-generating possibilities.

Transformed entire brand-wide operating model from centralized R&D operations to federated model that aligned functional SDLC accountability with product solution line owners. Transitioned responsibilities to become operations lead for Data Fabric and Donor Management solution lines. Led matrixed team of 50+ Product Management, Engineering, Project Management, DevOps, SRE and Testing practitioners across 12 distinct products, delivering 50+ back-end services and 500+ releases. Built template for best practices in new model adopted as the standard across all solution lines. Built new Plasma Donation Management System, a Blood Establishment Computer Software (BECS) Class II medical device, from ground up in less than 18 months. Achieved successful proof of concept (POC) using a mix of pre-existing software components and configuration of an LCAP deployed on dedicated cloud infrastructure. Managed planning, documentation and execution of designs consistent with FDA medical device regulations in support of 510(k) submission.

Functional owner of production operations for Medidata’s entire suite of clinical cloud products and platform services: SaaS Change Management, Release & Configuration Management, Release / Performance / Systems Engineering, Customer Technical Support, Multi-Cloud IaaS, Service Level Management, Customer & Regulatory Audit Support, Custom Solution Architecture, DevOps Toolchain, and IT Financial Management. Led team of 70+ reports and $30M+ annual budget. Accelerated delivery rate of product deployments from <200 in 2010 to >6K in 2020, a 30x increase over 10 years with only a 0.5x increase in operations staff in the same period. Developed and implemented true multi-cloud platform, with equivalent IaaS infrastructure management, product deployment / configuration and data management capabilities, spanning multiple AWS and on-prem (Cisco / VMware / BigIP / Hitachi / AWS DirectConnect) regions in US and Europe, while achieving and maintaining critical standards and regulatory requirements: 21 CFR Part 11, HIPAA, PCI, GDPR, ISO 27001, with regular SOC2+ auditing and reporting.

Created and led team of 6 accountable for developing and enforcing change management controls for customer-facing systems and hosting environments. Expanded role to encompass development of automated operations for full stack: OEM bootstrapping, virtual infrastructure, cybersecurity, database management and product installation / upgrade / segment configuration operations. Standardized deployment and configuration management procedures focused on automation. Authored dozens of SOPs, Work Instructions and supporting documents to augment Quality System with respect to SDLC practices and regulated system qualification procedures, all based on GAMP 4 and 5.