Nancy is senior director, global regulatory affairs for Eli Lilly & Company and has more than 25 years of drug development experience in the pharmaceutical industry. She currently leads the regulatory registrations group, the global labeling group, and the regulatory center of excellence. Prior to this, she held leadership roles in product safety, quality, and research. She holds a Bachelor of Science in Chemistry from Kent State University and joined Lilly as a chemist in discovery research.
Group Director, Global Regulatory Business Capabilities
Group Director, Global Regulatory Business Capabilities
Danielle obtained her PhD in biochemistry from Laval University Canada. After a 13-year career in microbiology drug discovery, she moved into regulatory operations where she managed several drugs at different stages of development in the US and EU. In 2014 Bristol-Myers Squibb began working toward replacing their older RIM solution with a new authoritative source for RIM, and selected the Veeva Vault RIM suite to accomplish that goal. Danielle has been the business lead for that effort from process definition/simplification to configuration, change management, and roll out.
Brian is a senior product manager on the Veeva Vault Clinical Operations team, where he is responsible for defining and delivering the product roadmap for Vault Study Startup. Brian joined Veeva in early 2017 after previous positions at Bioclinica and Informa Business Intelligence. As a product manager, he has overseen work in clinical systems integrations, data warehousing and analytics, and the collection, management, and analysis of market data regarding clinical trials, drug pipelines, and corporate partnerships, mergers, and acquisitions.
With over a decade of life sciences experience, Chris serves as a senior product manager in the Vault Quality family of applications. As a PM for Vault, Chris has been managing the quality application products since the first release of Vault QualityDocs, championing the unification of quality management, compliance platform, and usability themes in Vault from the beginning.
Michael is responsible for R&D value engineering at Veeva where he works with customers to determine the potential and realized value of the Vault applications. Mike comes to Veeva with more than 15 years of operational experience working in both pharma and CROs.
As vice president Veeva Vault EDC, Hugo is responsible for Vault EDC strategy, market adoption, and customer engagement. Hugo has spent the last 15 years in management consulting and professional services, helping biopharmaceutical organizations increase their productivity, innovate and grow.
Prior to joining Veeva, Hugo was a senior director of corporate strategy at QuintilesIMS, the world’s largest contract research organization. Before QuintilesIMS, Hugo held senior management roles in the R&D consulting practices of Deloitte and Accenture. In these roles, Hugo worked with seven of the top 10 pharma to help increase their returns on R&D investment and deliver innovative new operating models and technologies, often including eClinical and EDC.
Sandeep has over twelve years of experience developing regulated software platforms and applications. At Veeva, he is responsible for the roadmap, design, and delivery of the Vault Quality Suite. Sandeep previously led product teams at Deloitte, MobileIron, and NextLabs and his specialties also include risk management and compliance, enterprise mobility management, privacy, and cybersecurity.
Ashley brings over 15 years of clinical research experience to her role as director of Vault Study Startup. As a market owner, Ashley leads the market, project, and adoption strategy for the Vault Study Startup application. Before joining Veeva, Ashley was director of customer success at goBalto, Inc., another cloud-based study startup technology company. Prior to that, she held executive management-level positions overseeing global study start-up departments in mid-size and large CROs.
Kim has worked in the medical device and pharmaceutical fields for over 25 years, specializing in quality systems. At Sysmex America, Inc., Kim is a quality systems manager responsible for document control, supplier quality, CAPA, internal audits, and product release.
Amy is on the leadership team of the Development Business Systems Management group at Seattle Genetics, whose focus is on delivering on-time right-size clinical application solutions to improve efficiency and speed drug development. Her areas of expertise are Clinical Trial Management Systems (CTMS), Electronic Trial Master File (eTMF) systems, and quality and operational metrics.
Associate Director, Regulatory Systems and Information Management
Associate Director, Regulatory Systems and Information Management
Rich has been in the life sciences industry for over ten years operating entirely within the regulatory operations space. Currently, Rich runs the Regulatory Systems and Information Management group at Tesaro where he is responsible for managing the systems and processes within the Global Regulatory department.
As senior director of Veeva Vault CTMS, Henry is responsible for the overall market strategy and direction of the Vault CTMS application. He is passionate about making clinical operations software easier and simpler to use, as well as transforming CTMS into a more efficient and enjoyable software application. With over 31 years in life sciences, and 19 years in developing and implementing clinical trial systems and clinical data analytics, Henry is an expert in clinical operations software, business process optimization, and CTMS efficiency.
Mark is responsible for leading a professional services team implementing Veeva Vault RIM. Prior to joining Veeva in 2014, he spent 15 years in a variety of technology roles within life sciences at organizations such as AstraZeneca and Wyeth Research.
Graham is the product manager for Vault Reporting and Dashboards. He joined Veeva in 2015 and has worked on features across the platform including the Vault Object Framework, Audit Logs, and Expected Document Lists. Prior to Veeva, Graham worked as a strategy consultant for L.E.K. Consulting and in venture capital with Upfront Ventures. He earned degrees with highest honors in business administration and economics from UC Berkeley.
Steve is the managing partner of Gens and Associates Inc., a global life science consulting firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance. His early career was spent at Johnson and Johnson and then transitioned to consulting where he lead several global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton.
Joby George is a senior product manager responsible for the Veeva Vault Training product. Prior to joining Veeva, Joby spent 13 years at Sparta Systems designing and delivering regulatory and compliant solutions to the life sciences market.
As an industry expert and informatics leader, Sobe has over 20 years of experience building and leading global informatics teams and directing large, complex, global, and cross-functional enterprise programs. She is currently head of R&D informatics at Daiichi Sankyo. Sobe is differentiated in the industry with her unique background and ability to design strategic and innovative approaches to complex problems and programs, bringing together business leaders to align on strategic requirements that result in technology solutions which are well-designed, implemented, adopted, and impactful within the organization.
Wendy has held roles in quality, supply chain, and IT with a strong focus on software development and delivery, quality management systems, and clinical supply management. She started her career at Shell Oil as process chemist, transitioning into the pharmaceutical business working for ALZA, Johnson & Johnson, Janssen Alzheimer Immunotherapy, Jazz Pharmaceuticals, and most recently at Gilead Sciences where she has been leading the change management activities associated with the launch of Veeva Quality Docs globally.
Christie is the director of regulatory operations at Ionis Pharmaceuticals where she has lead the group for the past eight years. Ionis Pharmaceuticals, Inc. was founded in 1989 to pioneer the discovery and development of antisense drugs. Prior to her time at Ionis, Christie managed reg ops teams at Datafarm Inc. and PAREXEL. Over the years, Christie has enjoyed implementing new software, submission formats, and processes at Ionis.
Andy is responsible for Veeva Vault Tools and the Developer Platform. His team is focused on delivering a robust platform for rapid development of Vault Applications and easy-to-use tools to streamline management of Enterprise Vault deployments. Andy has over 20 years of enterprise software experience and has held product positions at NextLabs, Siebel Systems, and Accenture.
Jen has over 25 years of experience in the pharmaceutical industry focused on global clinical development. She has been with Incyte since 2016 as the head of Clinical Trial Logistics group. This group is focused on the optimization of study start-up activities to accelerate clinical development. Prior to that, Jen has worked in organizations including Shire and AstraZeneca.
Vice President, Site Collaborations and Patient Centricity
Vice President, Site Collaborations and Patient Centricity
As vice president of site collaborations and patient centricity, Rhonda Henry leads PPD’s commitment to building strategic relationships with physicians and patients across the world with the objective to bring more treatment options to more patients. As a breast cancer survivor, Rhonda understands the importance of involving patients in the clinical trial process, while also making potentially life changing therapies more accessible to patients.
Tim transitioned from academic clinical research to the pharmaceutical industry 20 years ago. He started in clinical development operations but gravitated to regulatory affairs given its remit to ensure good data and good science in the service of public health. Tim joined Veeva over a year ago to support RIM Registrations, XEVMPD, and IDMP.
Jeremy has been an industrial product manager for ten years, designing for life sciences, HVAC, and scheduling software. In his time at Veeva Jeremy has worked on Vault QMS and is currently designing exciting new products for Veeva’s clinical suite.
Paula is an advisor for the Regulation Information and Process Automation group at Eli Lilly. She received her BS in Pharmacy at Purdue University. Paula began her career at Lilly in manufacturing technical services and then held assignments in clinical trial packaging and labeling and quality assurance before arriving in global regulatory affairs. She has held director roles in CMC, advertising/promotions, and labeling before taking on this opportunity to lead the implementation of an integrated platform across global regulatory systems and processes.
Scott is currently a senior solutions consultant at Veeva focusing on the R&D space and primarily Veeva Vault Safety. Scott is a 20 year veteran of pharmacovigilance, medical information, and product quality in life sciences industry. He spent the first half of his career working for companies like Quintiles managing, implementing, and validating their global safety systems (Argus and Clintrace). During the second half of his career, Scott has worked for life science software companies like ArisGlobal, makers of ARISg, responsible for managing the global SC team and associate director of PV, driving the development of their product suites.
Karen has been in the life sciences industry for 19 years and with Veeva for the past six years, with expertise in Veeva Vault configuration and best practices. Karen is a principal consultant in Veeva’s R&D SMB Services practice, focused on the success of our R&D SMB customers through quality services.
Jeff is founder and CEO of IACT Health, a research management organization, and thirteen wholly owned and integrated clinical research offices. The companies conduct phase I through IV research in nearly every medical specialty: inpatient and outpatient, pharmaceutical, biotechnology, and medical device. His mission is to create a new paradigm of research that allows brilliant minds to innovate faster and to deliver those new ideas the patients who need them. Dr. Kingsley is the past chair of the Board of Trustees for the Association for Clinical Research Professionals which represents more than 13,000 clinical research professionals internationally.
George is a product manager at Veeva responsible for platform features related to lifecycle and workflows. He is currently focused on designing and implementing Lifecycle and Workflows on Vault Objects.
Ed has over 25 years of healthcare IT experience in the hospital environment and currently oversees the evaluation and implementation of various clinical information systems and data management platforms at Ora, Inc.
Ray is the SVP of product for Veeva Vault EDC. He runs the product management and engineering teams for Veeva’s data management applications. Before joining Veeva, Ray was the COO and head of product for Medrio, an EDC and eSource company. He has been developing software for most of his life in one capacity or another, starting with 6502 assembler at age twelve.
Eric has worked over 20 years in the life sciences industry helping customers fit the right solutions to meet their business operations. Currently, Eric heads up the R&D Solution Consulting group at Veeva.
Adam has been on a journey to build the industry cloud for life sciences since he left college in 2010. Starting his career at Zinc Ahead Ltd, he created Zinc’s first product management team. Their life sciences review and approval tool, Zinc MAPS, went on to win the Queen’s Award for International Trade twice in three years. Upon Veeva’s acquisition of Zinc in 2015, he made a dream move across the Atlantic to work on Vault PromoMats at Veeva HQ. Two years later, he now leads a core Veeva Vault Platform team, delivering content management functionality for all Veeva applications.
Jean-Christophe is director of product management at Veeva Systems, in charge of the Veeva Vault Platform security, which provides a unified access control model for documents and objects. Prior joining Veeva, he had 15 years of product management experience in B2B and B2C eCommerce and Partner Portal products, where enabling online collaborative flows preserving security and privacy is of utmost importance.
With over 18 years of experience in the life sciences industry, Rich has delivered regulatory-focused software and services to many of the world’s leading Pharmaceutical and Medical Device companies. He is currently the product manager for Veeva Vault Submissions Publishing.
As vice president site strategy, Jason is focused on ensuring that Veeva delivers market-leading clinical business operations solutions and that Veeva customers are successful. Prior to joining Veeva, Jason was the clinical documentation department head and TMF process owner at Vertex Pharmaceuticals. Jason was also the business owner for Vertex’s Study Startup Management System, a web-based application that was developed from the ground up to support the study start-up and site activation process. Jason has held a variety of roles ranging in clinical operations, regulatory affairs, and inspection readiness
Associate Director, Global Regulatory Business Capabilities
Associate Director, Global Regulatory Business Capabilities
John is an associate director with over 19 years of experience in the pharmaceutical industry in roles spanning regulatory operations and informatics at Bristol-Myers Squibb. He has played several key roles in the Enterprise Regulatory Business Management program leading to the evaluation, selection, and implementation of a new RIM capability for BMS. Most recently, he was the business lead for the Phase 2 deployment of Vault RIM.
David joined Veeva in 2016 as Vault product manager in the Development Tools team. He has built features such as Sandbox Vaults and Vault Compare and was instrumental in supporting configuration migration and reporting for many of the Vault component types. Prior to Veeva, he spent almost 10 years in engineering roles building applications, integrations, and APIs.
“Scott Mitreuter, Senior Product Manager for Quality, has 15 years of experience in Life Sciences. As a PM for the Vault Quality Suite, Scott primarily manages the QMS (Quality Management System) application and its built-in processes such as Deviations, Change Control, Complaints, Audits, Investigations, CAPA, and more.
Scott’s background and experience goes beyond managing and designing products for Quality, but also includes a strong Service’s background of Enterprise Software implementation, configuration, training, reporting, and validation.”
Angela has worked in the life sciences industry for over twenty years in various quality assurance roles. She currently works as head QA projects responsible for ensuring that projects within the quality area are monitored to completion and they meet the requirements of the organization, whilst being compliant and user friendly.
Bob is director of product management for the Veeva Vault Platform. He is responsible for Vault Java SDK, providing a powerful tool to extend Vault capabilities. He has an extensive background in enterprise platforms from data modeling to custom programming. He is passionate about making Vault a world-class platform for building industry applications, allowing customers to use Vault to handle their most demanding business application needs.
Patty is currently responsible for R&D IT solutions at Radius Health, including Veeva Vault Clinical, Quality, PromoMats, and RIM. Patty has been implementing and supporting R&D technology and informatics solutions for almost 20 years in the greater Boston area.
Sondra is a principal product manager at Veeva focused on Vault Clinical. Sondra’s passion for life sciences started with work in healthcare providers’ offices and migrated into clinical software. Sondra has over 15 years of direct experience with a wide range of different clinical research technologies.
Robert has over 20 years of combined regulatory affairs operations and information technology expertise in using, delivering, and supporting large-scale, cross-functional global projects and solutions. Robert is associate director, global development systems at Regeneron.
Tina has over 25 years of experience working in clinical research in both CRO, Pharmaceutical and Biotech environments with over 16 years of experience in management/leadership roles. She has successfully managed and set up several Strategic Alliance Partnerships. She has extensive expertise in GCPs, FDA regulations and system validation.
She has also lead Information Technology teams as the Data Management Business Partner in support of various EDC Platforms. Inclusive of managing ICON’s operational EDC Database build team.
Lisa is a director with Johnson & Johnson Clinical Operations. She currently leads a global cross-sector Site Initiation team that is focused on the optimization of study startup activities within J&J. Lisa has worked in the pharmaceutical industry for more than 20 years and previously worked in organizations including Alpharma and Hoffmann-La Roche.
Uri is responsible for the design, development, and overall success of the Veeva Vault RIM Suite. He has been building high performance software products for over 15 years. For the last 9 years at Veeva, he has helped life sciences companies adopt new innovative technologies. He has spanned both Commercial and R&D, and has worked closely on all three of Veeva’s software product lines.
Rolando is director of product management for the Veeva Vault Submissions Archive application. He’s worked with life sciences companies for over 15 years delivering software focused on the needs of regulatory.
Joanne is director of solution consulting for Veeva Vault EDC. She joined Veeva with 20 years of experience in solution innovation in the life sciences sector. Previously, Joanne spent eight years at Oracle delivering solutions for business challenges in both clinical and pharmacovigilance systems. Joanne has held senior technical positions at Schering-Plough and Bristol-Myers Squibb supporting those organizations with both their safety and clinical systems, respectively. Joanne was also the founder and partner in her own technology consulting firm which specialized in offering services for customers in the life sciences space.
Jamie has been in the life sciences industry for over 15 years, always in the regulatory operations space. Jamie currently oversees the Regulatory Operations group at Agios Pharmaceuticals where she is responsible for electronic submission management along with system and process management within the regulatory department.
Brent is currently the director of clinical operations for Allakos, Inc., a clinical stage company in the San Francisco Bay area. Prior to joining Allakos in 2017, Brent was the director of clinical operations for ZS Pharma, Inc. During his time at ZS, Brent worked with the clinical team to develop their lead drug candidate, Lokelma, for the treatment of hyperkalemia.
Kyle is a clinical product manager working to streamline Veeva Vault eTMF and CTMS processes and bring the latest and greatest enhancements to the clinical community at large. Over the last three years, Kyle has worked as both a Vault end user and a Veeva consultant, bringing with him not only a knowledge of how Vault works from the customer side but also the hands-on experience of consulting at some of Veeva’s largest clinical implementations.
Gareth heads up the dedicated TMF Operations Business unit within Syneos Health providing TMF services to over 300 current clients, either as part of a full clinical outsourcing, or dedicated standalone TMF services. With more than 20 years of top-tier CRO experience in drug discovery and development, bench science, and clinical research, Dr. Sully has distinguished himself in the creation of industry leading teams focused on exceptional customer delivery and the latest technologies to drive optimization and greater transparency in clinical trial data.
As technical practice manager for R&D Services, Todd assists customers with technical aspects of Veeva Vault Platform and R&D applications, including integration, data migration, single sign on, SDK, and solution architecture. Todd has been with Veeva Professional Services for ten years.
David is the clinical systems manager at Intersect ENT, a medical technology company dedicated to advancing the treatment of ear, nose, and throat conditions. With nearly 15 years in clinical systems with both medical device sponsors and an EDC vendor, David has a breadth of experience with multiple EDC, ePRO, IRT, and imaging platforms, and has supported two successful pivotal trials leading to FDA approvals of novel medical devices.
As vice president of Veeva Vault Platform product management, Peter is responsible for developing new and expanding upon existing capabilities of the Vault platform. Peter brings over 15 years of experience in product management designing enterprise software applications. Prior to Veeva, Peter spent several years managing Siebel’s Tools and Configuration features, led Oracle’s Fusion CRM product management team, and helped start the SaaS BI firm Birst in 2004.
Jamie has over 18 years of IT experience in the pharmaceutical industry. She has been with Daiichi Sankyo, Inc. since 2016 as the director/head of TMF operations. Prior to that she worked at Covance for eight years within the trial master file space. Jamie is a steering committee member for the DIA TMF Reference Model Working Group and on the operations committee and a director for the Health Sciences Records and Archives Association (HSRAA).
Todd has 18 years of experience in clinical technology across pharma, CRO, medical device, and research site organizations. He has been a volunteer contributor to the TMF Reference Model for six years and currently serves on the intiative’s Steering Committee. From CTMS to EDC, to eTMF and everything in between, Todd’s career mission is to improve human health through more efficient and more effective clinical trials.
Andrew has 20 years of clinical operations experience in the medical device and diagnostics industry. Andrew is currently global clinical affairs director at Integra LifeSciences, with responsibility for implementing and executing both pre and post-market clinical research strategies to generate and integrate global clinical evidence in support of Integra’s corporate wide business goals.
Joe has over 15 years of experience in the pharmaceutical industry, working in a wide range of functional areas including automation, technical manufacturing support, technology transfers, capital project delivery, validation, manufacturing, and quality. Joe has worked at Ultragenyx for two years and was the business lead and business process owner on a project to replace an existing TrackWise installation with Veeva QMS.
Melonie has more than 25 years of technology experience with expertise across multiple verticals – including life sciences, healthcare, manufacturing, and government. As vice president of medical device & diagnostics, she’s responsible for Veeva’s strategy in MD&D, customer engagement, business development, strategic alliances, and market adoption. Before her role in MD&D, Melonie was vice president, Vault Platform, where she was responsible for new market development, solution identification, customer engagements and go-to-market activities.
Karen is an assistant director at AbbVie Inc. She has 30 years of clinical trial-related experience specifically in areas of data management, system configuration, and project management. Karen currently leads the TMF Operations team, whose responsibilities include identifying and implementing processes to leverage the functionality of AbbVie’s eTMF. Karen has been working as an eTMF subject matter expert at AbbVie Inc. since 2016.