San Francisco Bay Area
I’m a Life Science IT, Quality & Compliance, Cybersecurity, and AI executive with 25 years of experience helping pharma, biotech, medical device, and GxP software companies build the infrastructure they need to operate with speed, compliance, and confidence. Today, my focus has expanded into AI — governing it, implementing it, and making sure life science organizations can adopt it in ways that are innovative, defensible, and audit-ready. At Vaxcyte, I lead AI initiatives alongside IT Quality, Security, and Compliance, sitting at the intersection of where emerging technology meets regulatory reality. Over my career I’ve worked with hundreds of organizations — from pre-commercial startups to established commercial companies — across IT strategy, cloud, SDLC, supplier audits, and GxP compliance. I know how to lead global teams, partner with senior leadership, and translate complex technical and regulatory challenges into clear, executable strategies. AI is reshaping what’s possible in life sciences. My job is to make sure the companies I work with can capture that opportunity without the compliance, security, and governance risks that come with moving fast in a regulated environment.
• Manage and optimize the Emerging Life Sciences & Innovation strategic solution offerings in alignment with current partnerships and available resources. • Develope robust IT frameworks, strategies, and GxP application implementations for over 300 Startup Biotech companies, empowering them to thrive in a rapidly evolving industry. • Lead strategic roadmap development and drive implementations of IT systems, compliant IT cloud strategies, quality programs, and content management strategies for emerging/startup Life Sciences executives. • Act as a trusted advisor and consultative CIO for executive-level IT projects in Life Sciences • Spearhead the development and growth of strategic partnerships and Solutions Development for 5+ partners, such as Veeva, to deliver cutting-edge solutions to the Life Sciences industry. Pioneer Go-To-Market strategies for over 15 Life Sciences offerings, supporting companies in their product launch and market expansion initiatives. • Conduct 20+ software supplier audits to ensure quality management practices. • Oversee successful business development strategies to bring in substantial new revenue and increased YOY revenue by an average of 30+% for market segment for the past 5 years.
• Directed global delivery of applications and implemented strategic plans for deployment and cloud delivery capabilities for over 25,000 applications • Oversaw rationalization of IT Applications Portfolio to ensure clients are utilizing current technologies and processes to reduce number of applications owned by Quintiles by 50% in 9 months • Established and implemented plans for application virtualization, application deployment and solutions for application delivery by understanding and implementing technologies that align to IT and business strategies • Managed the Application management and Application Factory team members (20+ team members) and global project teams in matrix organization for project delivery of IT solutions in validated environment
IT Business Relationship Director (Promoted from Associate Dir) • Developed and delivered global business IT strategies, roadmaps, and application projects, acting as the primary, global IT point of contact for 7 business units: Regulatory Affairs, Records Management, Regulatory Publishing, Biostatistics, Quality Assurance, Medical Writing, Medical & Scientific Services, and Biostats. • Acted as Executive IT Liaison for 10+ sponsors, such as Amgen, Lilly, and Pfizer. Developed streamlined business processes and facilitated seamless application integration with sponsor systems. • Led and delivered critical global enterprise IT platform solutions: Document Management solutions deployment (LiveLink), SAS, eCTD, Clinical systems, EDC and other systems. • Negotiated numerous $5MM+ contracts with vendors for new capabilities for customers. Managed IT vendors, including audits and contract negotiations. Achieved over $10 million in cost and infrastructure reduction via innovative technologies. • Conducted and supported 40+ customer, QA, and vendor audits, contributing to new business wins. • Awarded Quintiles' President's Award for innovative solutions and received 10+ awards for outstanding achievements.
• Advised and coordinated all systems strategies, implementations and compliance for 5 business units Regulatory Publishing, Regulatory Operations, Records Management, Quality, Clinical Data Management, and external client applications • Provide business process development expertise for Data Management, Clinical, Project Management and Regulatory Affairs. • Lead large application technology deployment projects for Regulatory, Medical Writing and Clinical Data Management. • Lead Business Solutions teams for sponsor connectivity for major pharmaceutical companies. • Lead and coordinated global application support for all applications for Regulatory, Records Management and Clinical Data Management and external client applications that are accessed from within Quintiles. • Project managed large application technology deployment projects and computer system validation efforts for Regulatory, Records Management and Clinical Data Management. Documented project scope, deliverables, project plans, resource usage, issue tracking and status reports. Evaluated project risks and developed contingency plans and coordinated validation efforts for all applications within support areas. • Investigate, propose and implement technology solutions for improvement of business processes and IT cost savings. Received Quintiles’ President’s Award for proposal and implementation of innovative solutions. • Coordinate electronic new drug application activities for IT for internal and external clients for submission to the FDA and other regulatory agencies. • Provide local application support for CoreDossier & secondary support for Documentum. Work on Submissions team to support publishing of NDA, NDS and MAA. • Install & maintain FDA submissions software and hardware and provide training and support for various technologies. • Provided technical guidance in proposal development, defense, and support during sponsor and FDA audits
Coordinated electronic NDA activities for Development IT and the FDA and other regulatory authorities. Provided local application support for CoreDossier and Documentum Electronic Content Management (ECM) & Document Management systems & Global Submissions support team to support publishing of over 20 NDAs, NDSs and MAAs. Installed and maintained software and hardware for applications on Windows and UNIX servers. Provided user and IT training and end user support. Functioned as primary point of contact for HR, Medical Affairs, and Government Affairs internal customer’s interests within IT. Assisted customers with IT standards and compliance. Coordinated inter-departmental process improvement and led new technology projects for clients and participate as lead on project teams.