SUMMARY:

• Experienced Leader in strategy, implementation, and roll - up-the-sleeves management of R&D IT - Drug Safety, Clinical Research, Clinical, Regulatory Affairs, Medical Affairs, Manufacturing validated systems
• Business-driven Leader with a dual scientific and computer science education with the technology understanding to work with business executives to align technology with business priorities
• Team Builder with proven leadership shaping and growing teams within IT and across business functions that break through organization barriers and silos to deliver results
• Organization Builder with experience in planning, budgets, hiring/retaining teams, establishing processes, managing finances and motivating people within high growth businesses
• Turn-around expert with a track record of turning challenged or high-cost environments into cost-effective successes driven by motivated and high-morale teams
• Strong negotiation skills through due diligence using off-shore outsourcing vendors
• Fluent in English, French and Spanish

TECHNICAL SKILLS:

R&D processes and IT systems: Clinical IT (CDMS, CTMS, EDC, eTMF, Clinical Trial Disclosure), Regulatory IT (EDMS, eCTD, labeling), Drug Safety and Pharmacovigilance IT (Adverse Event Reporting) Systems

Process Development/Biologics Manufacturing, disposable equipment and Automated Technology systems: S88/95, DCS/PAS, MES, historian, alarm management systems and electronic batch record, LIMS

Project execution: Initiation, Conceptual/Detail Design, Construction/Execution, Commissioning & Qualification

People Management: Building high performing teams, Situational Leadership, Quick-Firm-Fair decision making, Collaborative management

Quality: Change/Configuration management, Computer Systems Validation (21CFRPart11) and data integrity

PROFESSIONAL EXPERIENCE:

Confidential, Devens, MA

IT and Automation Director

Responsibilities:

• Build and Managed a team of 33 FTE. Responsible for capital and operational budgets ($18M in Capex and $11M in Opex)
• Responsible of all Information Technology/Automation programs, teams and needs for Process Development, Clinical and Commercial Manufacturing
• IT business analysis
• Automation (DCS/PAS, MES, interfaces with SAP, LIMS, Maximo) and in process monitoring (PI), multivariate analysis (Umetrics Discoverant, SIMCA)
• IT infrastructure (Data center, network, desktop/laptop, cloud vendors)
• Computer Systems Validation (SDLC, 21CFRPart11, GAMP 5)
• Led the strategy, planning and implementation of site-wide change initiatives to enable 1000+ users with innovative technology resulting in better user experience and increased operational efficiency
• Optimized the infrastructure to scale at a lower cost, and drove non-value-added capabilities to the cloud
• Directed all IT/Automation initiatives for the site expansion, with the build of a Biologics Development building and a Clinical Manufacturing building able to host 300 additional scientists and operator.
• As a member of the leadership Team, hired and led the evolution 33 IT Team from order takers to digital leaders
• Increased the technology user base by 100% creating a change implementation capability to support the replacement of manual and outdated processes
• Design the Multi-product capability Technology to host the technical transfer of an additional large molecule
• Designed and managed the IT Quality systems and validation following the merge between IT and Automation
• Responsible for interfacing with the various Regulatory Agency leading to successful FDA, and EMA audits
• Responsible for the data integrity program at the Devens site in accordance with the global directives

Confidential, Cambridge, MA

Director Research and Development IT

Responsibilities:

• Repositioned Development Sciences IT as a strategic asset by partnering with the Chief Medical Officer and Operations VP to focus on business systems that deliver higher value
• Rebuilt the IT Business Partner team to transform the group from order-takers to Functional Partners
• Reorganized the clinical, global regulatory and drug safety IT functions to align with new business strategy and ensure alignment with regulators; asked by the CIO to take on this additional functional leadership responsibility to mitigate risk during significant organizational change
• Enabled cost reduction, resource optimization and improved customer service via a near-shore support model
• Augmented the document management system capability with business analytics, document indexing, document imaging, and integration with third-party providers
• Reduced overall R&D IT costs 30% through vendor consolidation, challenging over-engineered infrastructure, and moving low value-added costs into the outsourced model
• Led all aspects of IT R&D in the due diligence for acquisitions, divestitures and system consolidation
• Drove the definition of Business IT strategy and architecture for global Development Sciences
• Lead a Project Management Office within Development Sciences IT to harmonize project practices (Planisware®)
• Managed the application design, infrastructure and implementation of a Clinical Integrated Data Repository, to enable the filing of several submissions
• Negotiated multi-million-dollar contracts, generating savings, both for time and material and fixed price bids
• Advised other business areas (Quality, Non-clinical) on IT Strategy, Technology Intelligence and Innovation
• Pioneered new technology ranging from complex datawarehouses to Sharepoint portal and mobile technology
• Strong experience with SDLC, Computer System Validation, 21CFR Part11, GxP, and SOX
• Championed the IT workstream Quality Risk Management process definition and with KRI/KPI definition for measuring Risks in Clinical Studies based on Patient Safety and Data Integrity
• Drove, along with business counterpart, the due diligence, RFP, and process redesign up to contract negotiations:
• Single Global Drug Safety Database (Aris Global Arisg/j®) on an on-demand (Saas) environment to streamline case intake, case processing, medical review, and reporting and bring with US/ROW/Japan under one workflow, and a single platform to improve reporting to FDA/ROW/PMDA
• Clinical/Investigator Portal due diligence, choice and pilot (ePharma solutions)
• Designed and implemented:
• Clinical Data Management System with Oracle® Pharmaceutical Application Suite (Oracle Clinical) with full access from off-shore FSPs
• Clinical Integrated Data Repository for multiple simultaneous submissions using SDTM standards (internal development based on Oracle, ETL Informatica®, and Business Objects®) with the goal of centralizing all clinical data across various domains and reusing clinical data for analysis
• Global Clinical Trial Management System (CTMS) and Investigator Database (Perceptive Informatics Impact®) to manage trials and obtain evidence-based metrics on the performance of investigators
• Electronic Data Capture (EDC) capability with Oracle RDC and near-shore support model with partners with the goal to become 80% fully electronic in 2011; goal was achieved with 100% for Phase III studies
• Clinical Trial Disclosure (Sylogent VCTR®) to register clinical trials and disclose results for several registries
• Pharmacovigilance Record Intake and Managed Output to replace the paper-based collection of adverse events and pregnancy cases; this project is integrated with Siebel Call Center to enable data capture by the Patient Services department and the PPD Call Center saving 5,000 hours in 2011, redirecting resources to more value-added tasks and drastically reducing double data entry; This program is now a COTS
• Partnering with external parties in accessing claims databases for statistical epidemiology studies
• Electronic Trial Master File (Phlexglobal Phlexiview®) which resulted in $1M savings and allowed complete document centralization for inspection readiness
• Electronic label management SPL (Glemser XMlabeling®) for xml label submission & management
• US/EU Adverse Events and Product Complaints Drug Safety Database (Oracle AERS®) and signal detection (Oracle Empirica®)
• Global Content Management and Submission Management System (Documentum®), Planning/ePublishing/Tracking/Electronic Submission (eCTD) (Liquent Insight®)
• Interactive Response technology pilot (inventory management, patient randomization)
• Electronic Outcome assessment pilot (Compact eCG, blood pressure monitors)

Confidential, Cambridge, MA

Senior Manager Application Support

Responsibilities:

• Built an internal operations team with new creative capabilities to lower support costs while more rapidly enhancing web based applications across multiple business lines
• Defined support model for applications for the incident management and normalize channels of escalation.
• Provided global support for drug development, and quality applications and platforms for over 3,000 users across multiple geographies
• Implemented the Quality Management System for QA, QC and IT
• Led the Support and application upgrades across for Drug Development, QA platforms.
• Managed the system integration workstream and implementation during the Biogen and Idec merger, leading to system centralization, reducing the maintenance overhead and improving the TCO of applications

Confidential

Manager

Responsibilities:

• Led, Implemented and support of Drug Development platforms

Confidential

Global Manager

Responsibilities:

• Designed and managed internal development:
• Audit Management system for mobile auditors in compliance with ISO 900x norms
• On-site billing system for invoice generation at completion of the audit report to accelerate payments.
• Quality, Safety, and Heath Environment system
• Business Intelligence and reporting system

Confidential

Senior Project Manager

Responsibilities:

• Led and implemented the roll out of the project/portfolio management system, electronic data management system, electronic submission system (Documentum) and ERP interfaces.
• Team leader of seven employees and contractors; Managed capital budgets.
• Goal achieved in reducing the drug development cycle time from eleven years to ten years
• Electronic Submission System (Core Dossier®); goal achieved to provide a review aid for AFSAPPS

Confidential

Project Manager and business analyst

Responsibilities:

• Drove the electronic content management system implementation for Clinical Research and Regulatory Affairs
• Supported the home-grown Safety Database
• Principal IT liaison with AFSAPPS and EMEA auditors
• Performed vendor audits
• Contributed to the design of the Quality manual and computer system validation policies