SUMMARY:

• Information Technology executive with proven ability to develop and execute IT strategies in alignment with business objectives.
• Offers over 25 years’ experience automating Life Sciences/Pharmaceutical industry.
• Demonstrated ability to build strong, dynamic teams which focus on business issues to increase revenue and reduce operating costs.
• Problem - solver with a record of success in creating robust IT architectures and infrastructures with a team of 70 with $13M Capex/Opex.

EXPERTISE AREA:

• Strategic and Operational Planning
• Mergers and Acquisitions
• Operational Change Management
• Program and Project Management
• Business Intelligence
• GxP Regulatory Compliance

PROFESSIONAL EXPERIENCE:

Confidential

Management Consultant

Responsibilities:

• For the Development organization, IT projects were not always aligned with business goals and objectives resulting in increased IT costs. To address this, developed a portfolio management process which aligned the IT projects with the business. Thus, allowing the business to move from ad-hoc IT decision making to clear business-aligned projects which will support the business to meet their goals. Did not reduce IT spend, but created a focused effort around prioritized projects.
• The cost of integrating various commercial systems was increasing which was diminishing the original business value of the systems. To reduce this increasing cost, managed a global team to evaluate e-Clinical Platforms (fully integrated suites of systems to support clinical trials) with an emphasis on Clinical Trail Management System(CTMS) and Clinical Data Management System(CDMS). Key business components of the e-Clinical platform assessed during the evaluation were, CTMS, CDMS/EDC, IVRS, RBM, Site Payments, Budgets, and Investigator Master Data. The benefits are still being realized as the company is moving toward a single platform with no integration costs. Saving >$1M per year.
• To salvage a project that was going to miss a regulatory compliance deadline, stepped in as project manager for the Unique Device Identification (UDI) compliance initiative. Managed the global upgrade of all systems from R&D, Artwork, Manufacturing/Logistics, finance and reporting systems. Met the September 2014 deadline for labels and packaging.
• Interim Global Director of PPMO Operations. Executed the global rollout of a new portfolio/project management methodology. Led the team on the development of PPMO-Operational processes including vendor and contractor management, on/off boarding, and training. Successfully rolled out the new methodology globally and improved executive visibility to all capital projects.
• To create a post-acquisition game plan for a recently acquired company in Brazil, conducted an integration assessment between corporate headquarters and the satellite company. Focused on areas for quick-wins and their dependencies. Analysis included assessment of SAP rollout to regional office vis-à-vis ERP integration, revamped business processes to support financial reporting, distribution and alignment of sourcing channels. Delivered a portfolio of projects, dependencies and estimates for short and mid-term benefits.

Confidential, Mattawan, MI

Sr. Director

Responsibilities:

• At the onset of this assignment, there were no controls in place for the review, approval, and tracking of projects across the organization. To address this gap, developed a portfolio management governance structure and introduced project management skillset into the organization. Improved system delivery time by creating a project and portfolio management process to improve project delivery, transparency, and communication. Established a method for estimating 5-year ROI for every project to ensure business benefit and used to assist in project prioritization.
• The portfolio management process was adopted across the organization for all capital expenditures, scientific, facilities, and IT. Chaired this Appropriations Committee.
• Reduced operational costs by increasing virtualization capacity to 80% in the data center. Installed Cisco UCS servers, Nexus switches and Unified Computing System Manager. Refer to Confidential Research case study.
• In the down-turn economy post-2008, adopted a “make more with what we already own” approach. Directed a team for the re-implementation of Finance and HR systems exploring new/unused features over new business processes. Built a data warehouse over existing source systems to alleviate costly integrations and enhancements. Enabled secure external reporting for sponsors. This resulted in the cost avoidance of millions on new systems.
• To address the issue of an unstructured, inefficient study quoting process, led a team for the delivery of a cloud-based solution which automated the costing of study proposals. Utilized commercial software to allow customers to tailor their studies and get instant quotes. Projected $1M/year savings and an additional of $750K/year upselling. Integrated with SFDC.
• With over a million square feet and 540 animal rooms, it was difficult to maintain computer carts in working order for use in the vivarium. Directed an R&D team to introduce mobile tablet technology with improved efficiency for lab operations of $500K/year.

Confidential, MI

Responsibilities:

• Due to no central oversight of study design and pricing, study costs were skyrocketing and need to be curtailed. Many study managers outbid each other for the same external resources without knowing it. To address this and other study planning issues, directed the development and implementation of Siebel for Clinical Trials Management. This $3.5M project saved the company >$1M/year on vendor management, visibility to study costs and volume discounting.
• To address the complex global tracking of adverse events in animals being administered company products, managed the configuration and implementation of PV Works, a pharmacovigilence system for the collection, management and reporting of adverse events in animals both in clinical trials and post-marketing use. Worked diligently with the company to set standards for future release of the product.
• To ensure IT and business resources were properly allocated and managed across IT initiatives, led a team in the implementation of a portfolio management tool, Changepoint (Compuware), for all of Animal Health IT. This tool created visibility across all projects, all divisions and enabled elimination of resource conflicts.
• Led the Veterinary Medicine system alignment/integration effort after the acquisition of Pharmacia. Coordinated the comparison and assessment of systems and planned for the migration to chosen systems. Coordinated the technology move of relocated office and lab workers’ equipment from Connecticut to Michigan.

Sr. Coordinator

Confidential, Groton, CT

Responsibilities:

• To reduce the time and effort to maintain the Trial Master File, both electronic and paper, led an international team to implement an eTMF over OpenText and Kofax technologies. Streamlined the collection of documents to reduce shipping and storage, including at-site scanning into central repository. Created a dynamic metadata-driven repository for accurate placement and quick access. Integrated business practices globally. Deployed to over 50 countries. Annual savings $6.3M.
• Submission Support - IT point person for Voriconazole drug submission teams for any IT issues that arose during the final preparation of the regulatory submission.
• Strategic planning for the enhancement of document management systems. Advisor on system selection and migration strategies. Managed the upgrade of a homegrown collaboration system to Oracle 8. Included PDF and HTML rendering with full text search on all documents.

Confidential, Edison, NJ

Senior Associate Consultant

Responsibilities:

• Designed a surveillance system to monitor and investigate trades that raise exception flags (potential insider trading) to ensure compliance and to pre-empt an SEC investigation; e.g. short-trades, cherry-picking, etc.
• Analyzed and aligned U.S. and Canadian business processes for trade promotion, account planning, and funds management. Assisted in the process reengineering. This reconciliation set the framework for an SAP installation. (Best Foods)
• Designed a common data warehouse to support account profitability and planning for both U.S. and Canadian operations. Data model incorporated ACNeilsen market data for trend analysis across labels, brands, products, and market sectors. (Best Foods)

Confidential, Groton, CT

Software Developer

Responsibilities:

• Assigned to a global team to build an in-house Clinical Data Management System (CDMS). Working with global business members, defined global processes as a foundation to this effort. Delivered Master Data Management module for the creation and management of eCRFs to be used for printing, in-house data entry and remote entry. This system would maintain global standards.
• Medical Dictionaries - New Terms Review: Designed and managed a client/server project to process uncoded medical terms. Project included automatic submission of terms during data entry, secured-dual-sign-off environment, and automatic update of master copy of medical dictionaries.
• Worked as an Oracle DBA designing databases for in-house applications. Specialized in fine tuning databases for optimal data input and retrieval.