Gary Hoke, MBA, PMP®

Raleigh, NC 27614

Objective

IT executive management position that will leverage my leadership, management and technical skills to deliver innovative enterprise solutions using emerging technologies that provide transformative value to the organization, its’ partners and customers.

Summary of Qualifications

Innovative, results-oriented IT Executive with 30 years of leadership, management and technical experience. Proven expertise in leading global cross-functional teams within dynamic, fast paced organizations. Excellent interpersonal and communications skills. Specific areas of competency and accomplishment include:

Professional Experience

Duke University School of Medicine, Durham, NC 2022-Present

Director, Research Technology Solutions

· Collaborate with Duke University School of Medicine leadership, researchers, and key stakeholders to understand research technology needs.

· Develop and drive strategic technology roadmap that ensure scholars have access to innovative and specialized IT services that enable transformative research.

· Manage and coordinate operational IT services that directly serve the researchers, particularly in the areas of Basic Science, Translational Research, Clinical Research and Data Science.

· Collaborate with IT leaders to implement best-in-class technology platforms that support and advance research technology strategic plan.

· Build partnerships with research study teams, research leaders, and other key stakeholders, ensuring that technology consultations for complex studies are addressed in a timely manner while institutional solutions and guidelines are developed over time.

· Manage and maintain portfolio of research technology services available to researchers and ensuring delivery and support excellence from direct reports and IT partners.

· Responsible for IT security of School of Medicine systems and applications to assure compliance with Duke ISO and regulatory policies and standards.

The Duke Human Vaccine Institute, Durham, NC 2019-2022

Director, IT

· Led Information Technology (IT) team to develop and implement the overarching technology strategy and initiatives of the Duke Human Vaccine Institute (DHVI).

· Managed DHVI IT governance policies and best practices for Enterprise Architecture, IT Service Management, IT Program Management, IT Security & Data Provenance, and Business Continuity & Disaster Recovery.

· Oversaw vendor evaluation, solution analysis, selection, implementation, validation, operational delivery and support of COTS and SaaS systems including specimen management, data informatics, clinical, ELN and LIMS applications.

· Worked collaboratively with researchers and business managers to propose compelling technology solutions based on requirements outlined in RFPs for grants and contracts with the NIH, DAIDS, DMID, CDC and other sponsors.

· Facilitated development of appropriate technology standards to ensure that lab research programs, grants, and contracts are well integrated within Duke Health, and DHTS operational IT infrastructure, support strategy, and operational plans.

· Partnered with senior leadership in the School of Medicine (SOM) OASIS group, Duke Office of Information Technology (OIT), Duke Health Technology Solutions (DHTS) and Duke Information Security Office (ISO) to advocate for the needs of DHVI researchers in conjunction with strategic institutional IT initiatives.

· Responsible for IT security and regulatory compliance program that encompasses standards including NIST, FISMA, FedRAMP, GCP, CGMP & FDA 21 CFR Part 11.

PAREXEL International, Durham, NC 2018-2019

Principal Consultant, eClinical Program Management

· Provided program management, administration and leadership across globally diverse operational and project teams (U.S., U.K. & India), in order to ensure on time, on budget delivery of eClinical platforms to PAREXEL clients.

· Served as key operational interface with biotech and pharmaceutical clients responsible for leading program steering committees, formulating strategic plans and managing cross functional team collaboration.

· Led and managed project managers within each eClinical application to achieve project objectives within budget, schedule and according to project specifications.

· Ensured programs and projects are designed, developed, delivered and supported in compliance with quality management systems, 21 CFR Part 11, relevant GxP regulations and other applicable client related standards/quality requirements.

· Accountable for financial project tracking and control, including resource utilization, time spent, project realization and monthly revenue recognition.

· Responsible for assisting with creation and review of client proposals and SOWs based on high-level business and functional requirements.

· Pursued business development opportunities with existing clients based upon new or changing business or regulatory requirements.

· Managed stakeholder relationships with client and direct and/or in-direct (hired by client) subcontractors as required for successful execution of client projects.

· Worked collaboratively with functional line mangers of business analysis, software engineering, validation and quality assurance teams on supervision and performance management of project team members.

National Agents Alliance, Burlington, NC 2013-2018

Chief Technology Officer (CTO)

· Led team of talented technology professionals located in U.S. and India focused on delivery of robust IT solutions to company staff, agents, carriers & customers.

· Managed IT governance policies and best practices for IT Service Management, Program Management, Systems Development Lifecycle (SDLC), Security and Data Privacy, Enterprise Architecture, Business Continuity & Disaster Recovery.

· Accountable for performance management of IT service teams which include Governance, Software Development, Business Intelligence & Analytics, Web Optimization & Analytics, IT Operations (DevOps/Security) & Help Desk.

· Oversaw agile-based software development team that developed and supported portfolio of commercial and custom SaaS applications specifically designed and integrated to optimize insurance and investment industry processes.

· Responsible for IT security and regulatory compliance program that included PCI, HIPAA, HITECH, NACHA, SAS 70, SSAE 16, NIST, COBIT & ISO 27001.

· Reduced IT operational spending by $586K over 3 years within first 15 months.

Aptiv Solutions, Durham, NC 2011-2013

Vice President, Global Information Technology

· Led global team of seasoned IT professionals that support offices located in United States, United Kingdom, Germany, Switzerland and ten other countries.

· Provided strategic vision for IT services delivered to 850+ employees worldwide.

· Performed technical due diligence on IT systems and infrastructure of acquisition targets and lead planning of IT integration efforts. Two completed in 2011.

· Negotiated and managed vendor contracts for implementation and maintenance of hardware, software and security assets critical to global IT infrastructure.

· Responsible for performance management of IT service teams which include Governance, Applications, Operations, Network/Communications and Support.

· Completed multiple data center consolidation projects in the U.S. and E.U.

· Oversaw assessment, selection and implementation of SaaS-based clinical trial management system (CTMS) and electronic trial master file (eTMF).

· Ensured that GxP and business critical systems were compliant with company policies, SOPs and regulatory standards (i.e. FDA, ICH, etc.).

· Represented IT during internal and sponsor quality audits.

· Developed and managed annual capital and operational budgets.

INC Research, Raleigh, NC 2004-2011

Director, Enterprise Applications & IT Governance Services

· Led global team of project managers, business analysts and software professionals that manage, develop and maintain world-class enterprise systems that generate revenue, reduce operational costs and drive process efficiencies.

· Managed collaborative business relationships with members of executive management (CEO, CFO, COO, CIO, VPs) to gather requirements for strategic business initiatives and analyzed how these align with strategic IT objectives.

· Analyzed existing business processes and implemented innovative technologies that transformed them and capitalize on economies of scale as company grew.

· Oversaw IT program management process used to determine which positive NPV projects best aligned with business goals and IT capabilities for implementation.

· Worked collaboratively with IT Operations and Networking teams to develop comprehensive disaster recovery and business continuity plans.

· Responsible for contract, SOW and SLA management of third-party vendors.

Education

North Carolina State University, Raleigh, NC

Master of Business Administration (MBA) 2009

Financial & Services Management concentrations

Master of Engineering 2000

Computer & Electrical Engineering concentrations

Bachelor of Science in Electrical Engineering 1997

Bachelor of Science in Computer Engineering 1996

Minor in Economics

Certifications

· Project Management Professional (PMP), License #443414

· Information Technology Infrastructure Library (ITIL) v3 Foundation, License #888482

· Certified Scrum Product Owner (CSPO), License #165434

· Certified Scrum Master (CSM), License #174244

· Amazon AWS Certified Cloud Practitioner (2018-2021)

· Six Sigma Green Belt Certification

Professional Development

· Hive Global Leadership Program

· Management by Strengths® Training

· Center for Leadership Studies® Situational Leadership Training

Honors and Awards

· DHVI Core Values Star Pin Recognition Recipient (2019)

· High Performance Team Award, INC Research - Acquisition Integration Team

· Competent Toastmasters (CTM) Award, Toastmasters International

Professional Affiliations

· Member, Project Management Institute (PMI), North Carolina Chapter

· Member, Duke Project Management Community of Practice

· Member, Society of Information Management (SIM), RTP Chapter

· Member, Triangle Part Eleven Electronic Records Stakeholders (PEERS)

· Member, Wolfpack Investor Network (WIN)

· Mentor, MetLife Digital Accelerator powered by Techstars, 2018-2019

· Board Member, The Widernet Project, 2015-2018

Please visit http://www.garyhoke.com for more information.