Certified project management professional and licensed, board-certified podiatrist with twelve years of pharmaceutical and biotech industry experience that includes: - Project management of all aspects of drug development programs: . * Preclinical and translational . * Phase I through IV Clinical . * Commercialization and post-marketing . * Manufacturing and Clinical Supply . * Regulatory submissions - Project Management Office setup, including systems, tools, processes, and staffing. - Business process analysis, design, and implementation using LEAN/Six Sigma methods - Organizational strategic planning - Business continuity planning - Pharmacovigilance and post-marketing safety surveillance Proven track record of solving problems and delivering results using strong analytical, negotiating, decision-making, and communication skills at the executive level. Specialties: PMP Certified Project Manager Program Manager/Program Management Project Portfolio Manager/Portfolio Management Project Management Office/PMO Business Analysis/Business Analyst Project and Program Risk Management Lean/Six Sigma process design, process analysis, process re-engineering, proces improvement Capability Maturity Models Therapeutic Program Management Safety Surveillance / Pharmacovigilance Strategic Planning Business Continuity Planning
Senior Director Project Management
Since May 2011
- Provide leadership, direction, and oversight of project management for the therapeutic area development programs; supervise other Therapeutic Area Project Managers. - Development and company-wide implementation of project management methodologies, best practices, SOPs, systems, templates, and tools. - Promote and adopt a project management culture throughout the organization. - Integrate project data across the organization, and provide consolidated project information and reports to executive leadership, therapeutic area heads, and functional department heads. - Develop a project office structure that enables achievement of organizational and departmental project objectives. - Work directly with Senior Management to plan, initiate and manage strategic projects for the execution of business strategies and achievement of organizational goals and objectives.
Senior Director, Drug Safety Surveillance
August 2007 --- December 2010
Led strategy development and implementation for the department, focusing on systems implementation, process design and improvement, and resource and cost modeling. Managed the CI project portfolio; identified, prioritized, and led continuous improvement projects to enhance the quality and efficiency of operations, processes, systems and services in alignment with departmental and organizational strategies.
Director, Investigator-initiated Research
January 2006 --- July 2007
Developed the department’s strategy, operating plans, and team goals. Developed ad-hoc reporting methods to support business needs, and directed the activities of personnel responsible for generating these reports. Developed performance metrics, baselines, and targets to drive business process and system improvements.
Director, Process and Information Management
January 2004 --- December 2005
Provided operational support to the Medical Division in various capacities, including process and organizational design, resource capacity and forecasting models, business systems ownership and governance, and Project Management Office support.
Senior Project Manager, Phase III-IV Clinical Programs
June 2001 --- December 2003
Provided project management support to the Phase III-IV clinical trial programs for Relpax and Caduet, including management of program-level budgets, development of the annual operating plans, management of regulatory submissions, overseeing study managers in managing clinical trial budgets, timelines, and deliverables, and identification and management of program variances, risks, and issues.
Business Analyst & Client Project Manager
January 1995 --- May 2001
Responsible for the full lifecycle of custom application development and implementation, including business requirements analysis, proposal and SOW generation, client relationship management, project management, system implementation, customer training, ongoing support, and overall customer satisfaction.
Owner, private practitioner
August 1987 --- December 1994
Private practice of podiatric medicine and surgery, with a focus on pediatrics and reconstructive foot surgery.
AdaptabilityAnalytical thinkingCollaborationCoordinationCreative thinkingCritical thinkingDependabilityFlexibilityIndependenceInnovative thinkingInterest in knowledgePerspectiveProactivityProblem solvingResponsibilityResult OrientedService orientedStrategic thinkingWillingness to compromiseTrust
Skills and Expertise
Analytical skills Analyze data Interact with physicians Interpret dataCommunicate effectively on different company levelsCollaborate with project teamCoordinate projectsDevelop study timelinesForecasting of drug productInteract with physiciansLate-stage regulatory filing (MAA, BLA)Lead teamsInterpret research resultsManage multiple projectsManage risksManage study budgetManage study supplymanaging a small teamPlan work to meet objectives and deadlinesPlanning clinical studiesproject managementProvide medical insightsReview clinical study reportsReview data interpretationReview exclusion criteriaReview inclusion criteriaReview medical reportsReview protocolsReview study protocolsReview the interpretation of dataReview vendor metricsReview vendor reports
DPM in Podiatric Medicine from New York College of Podiatric Medicine in 1986
in Biology from Saint John's University in 1982
Training and Certification
Diplomate, Board Certified Certification
Project Management Professional (PMP) Certification
Six Sigma Green Belt Certificate Certification