Arthur L. Drury, PMP

Senior Clinical, Informatics and IT Program Manager with extensive background in project management, computer systems validation, business analysis, architecture, application support, infrastructure and technology strategy. Experienced building high performance teams, project planning and documentation, change control, release management, regulatory compliance, CAPA resolution, managing risk and maintaining strong relationships with clients, vendors and business partners. Primarily support Oncology, CNS, Respiratory and Anti-infective therapeutic areas. Strengths: Leadership, analytical, communication, negotiation and presentation abilities. Assets: creativity, customer focus, “hands-on” problem solving.

Summary: Lead efforts to design, implement, deploy, administer, support, and validate systems for Drug Development, including Drug Safety, Regulatory, Clinical Operations and Medical Affairs organizations.

·         Supported Pharmacovigilance in the design, development, deployment and support of tools for adverse event reporting, EDC, signal detection, data analysis and prediction as well as aggregate and analytical reporting;

·         Responsible for integration of third-party software applications, vendor management, new product evaluation, business and functional requirements definition, requirements analysis, test planning, test case development and test execution;

·         Skills include MS Project, Documentum, SharePoint, ICE, UML, RUP, SDLC, LIMS, ARISg, ARGUS, Agile, Spotfire, EDC, CDISC, SDTM, MedDRA, WHO, ICH, ITIL, SAS, Remedy, cGxPs, SOPs, 21 CFR Part 11, CSV. PMP certified.

GSK Consumer Healthcare                                                                         Mar 2016 - Present

Lead Project and Portfolio Management, accountable for budgets, timeline, staffing, vendor and resource management, for roughly 70 active studies globally across three categories: Oral Healthcare, Respiratory and Pain Relief. Responsible for monthly status reports and presentation to the CMO and Senior Leadership Team. Frequent interaction with peers in Regulatory, Quality, New Product Development, Finance and Commercial organizations. Also lead capital projects and key initiatives for the VP of Clinical Development and Medical Affairs.

Sanofi-Aventis Pharmaceuticals Corporation                                          Mar 2015 - Feb 2016

Led development and deployment of ITS Business Solutions and applications supporting global Clinical Trial Management, including Risk Based Monitoring, Electronic Data Capture and data analytic systems for use by Sanofi clinical staff worldwide. Also responsible for Quality and Compliance oversight, application support and process improvement initiatives. Familiar with Medidata Rave for EDC and CDMS, IMPACT CTMS and Documentum EDMS.

Novartis Pharmaceuticals Corporation                                                    Jan 2010 – Feb 2015

Provide Quality & Compliance oversight for the highest priority projects across the Oncology portfolio, with annual budgets totaling ~$20M annually, including COTS, internally developed and mobile/E-Commerce applications, SaaS, inSite, Documentum, Veeva, Salesforce.com and SharePoint platforms. Business groups supported include Medical Affairs, Drug Safety, Clinical Development, US Commercial IT and Corporate (e.g. HR, Finance and Office of the President). Duties require frequent collaboration within and across business units at all levels in the organization and a clear understanding of GxPs and FDA regulations.

Led project management and business analysis for the design, development, installation and deployment of the MINova QUEST medical enquiry and contact management system to Global Medical Affairs (OGD/GMA) staff worldwide, a project which received the President’s Award in 2011 and saw medical enquiry response times improved by 200%. Responsible for eliciting, organizing, translating and simplifying user requirements, assisting sponsor with the business case, documenting business processes, developing use cases, designing test cases, change management, ensuring project quality, contracts and vendor management, assignment of tasks, budget and deliverables tracking.

Hoffmann-La Roche Pharmaceuticals, Inc.                                                                2006-2009

Responsible for Drug Safety systems initiatives, including a global implementation of ARISg 5.1 and integration of Siebel CRM for the Roche U.S. Call Center. I participated in the Global Informatics Management Team in defining strategic IT initiatives for Pharmacovigilance. Prepared and presented business cases. Reviewed, defined and negotiated project schedules and budgets. Conducted Voice of Customer (VoC) surveys and workshops. Coordinated and facilitated User Acceptance Testing (UAT). Successfully completed integration of ADVENT and Siebel CRM systems for electronic transfer and case reconciliation of Adverse Events to the Drug Safety system. Managed and cultivated relationships with senior executives, sponsors, other functional areas and third-party vendors.

I completed consulting engagements leading implementation of global solutions for PV and Drug Safety, including major ARISg drug safety system upgrades. Responsible for system integration, installation, configuration, testing and support, managing MedDRA dictionary upgrades, implementing best practices, development of training materials, training delivery, and communication of project status and deliverables to stakeholders, including the executive steering committee. Implemented  ARISg 5.0 Adverse Event Reporting System with E2B gateways.

Aventis Pharmaceuticals                                                                                            2002-2004

Held roles in Software Quality Assurance and Scientific Computing, developing technology solutions to meet business needs. Led teams in global software development for business and drug discovery applications. Led genomics and proteomics database applications development and support, including a web-based portal that provided a single point of entry to globally dispersed scientific systems, as well as implementation of a Siebel SFA system.

Johnson & Johnson Ortho-Clinical Diagnostics (OCD)                                                   2002

Transfusion Medicine Division

Led IVD product teams in Global Immunohematology product development, a product line representing a $270M annual revenue stream. Responsible for product development, project plans, processes and documentation. Duties included communication of project plans and progress to senior management, risk assessment, budgets, proposals and statements of work.

Hoffmann-La Roche Inc.                                                                                          

Intel Corporation                                                                                                      2000-2001

Led a team responsible for product management, marketing, project management and architecture of next-generation networks including IP-based PBX and softswitch platforms.  Performed competitive analysis and market research. Formulated project plans, product plans, specifications and requirements.  Duties included leadership of cross-functional teams, P&L attainment, building teams, proposals, vendor management, product lifecycle management, business plans, white paper generation, trade show support and product launch.  Frequent interaction with customers and senior management.

Bell Labs CTO Office, Technology Strategy and Assessment - Senior Manager - Murray Hill, NJ

Coordinated and developed Bell Labs’ global R&D and product line plans linking research, business, and market strategies to product line and technology plans. Provided strategic planning expertise and consultancy to the Bell Labs scientific community, reporting to the CTO.  Duties included strategic planning, technology assessment, competitive analysis, project management, development of department web site and market research. Helped formulate technology acquisition and intellectual property strategies for executive leadership.

Lead RF Systems Engineer - System Integration and Test – Whippany, NJ

I managed a team of 16 computer scientists and engineers in the development of mobile networks. Attained a drastic reduction in faults and product development interval for the Flexent platform, the culmination of a $200M R&D effort.  The successful deployment and subsequent release of the Flexent platform, on time and with virtually zero defects, was a first for the division.

United States Air Force Reserve                                                                                      1987                                                              

Lieutenant (1LT) – 14^th FTW, Columbus AFB, MS

Reported to active duty for pilot training.  Instruction included courses in controls, hydraulics, powerplants and electrical systems, as well as navigation, mission planning, and aerodynamics.

New Jersey Institute of Technology

Newark, New Jersey: BSME, EE - 1986