New York City Metropolitan Area
Industry Experience: Early Clinical Development and Commercial Launch Manager for Pharmaceutical products. Commercial Launch Manager for Class III Medical Devices, Pharmaceutical R&D and Manufacturing, Pharmaceutical Warehouse and Distribution, Infrastructure, Software Development, Testing and Validation; Software Quality Assurance, Compliance, FDA cGMP/cGxP/Quality System Regulations, Telecommunications, and Retail Sales/POS systems. Pharmaceutical 15 years: Novartis Pharmaceuticals, Merck, Express-Scripts, LabVantage, QualityWorx Early Development and commercial Product Launch Manager for Pharmaceuticals, Warehousing and Distribution Systems. Responsible for SDLC and global deployment of LIMS software application for life science clients. Championed Business Impact Analysis, Disaster Recovery Planning and Compliance projects to meet corporate and FDA regulations applicable to pharmaceutical industry. Medical Device: Stryker, NY Blood Bank, QualityWorx 5 yrs - Program R&D Management for NPDP and NTDP Class III implantable, orthopedic medical devices (shoulder, hip, knee and cranial implants; cements), subject to strict FDA QSR 820.30 regulations. My portfolio consisted of managing all aspects of the NPDP project lifecycle for Class III implantable devices from inception to commercial launch. This included interfacing with all key cross-functional business units, such as Product Development, R&D Engineering, Reliability Engineering, Advanced Operations, Marketing, Sales, Regulatory, Compliance, Clinical, Sterility, Quality Assurance, Validation Testing, Manufacturing and Packaging. Telecommunications: AT&T Wireless Communication – 10 yrs. – National manager for wireless telecommunications and retail sales. Responsible for software development and deployment to the retail sales organization. My leadership reduced networking, data and voice engagement costs by 60% (from 150K to 60K per implementation.
US / International Commercial Launch (11 Years) Directed end-to-end commercial launch strategy and execution for multiple indications across Cardiovascular, Immunology, Dermatology, Rheumatology, Respiratory, and Neuroscience. Led cross-functional teams to deliver launch objectives through advanced project management, introducing MAP tracking and accelerating timelines by 10 months, generating $1M+ in early Rx revenue. Delivered strategic planning, scenario modeling, and execution for major brands including Rhapsido, Remibrutinib, Pelacarsen, Ligelizumab, Cosentyx, Kesimpta, Xolair, Utibron, Seebri, Arcapta. IHD Medical Affairs Oversaw Cosentyx life cycle management and new indication launches. Managed integrated product development and medical tactical execution for Dermatology and Rheumatology indications (PsO, HS, PsA, axSpA, JIA, ERA, JPsa). Delivered cross-functional alignment, program management, and tracking initiatives to ensure seamless execution. Early Clinical Development (US/Global) Directed strategic portfolio management for 20 early-stage assets in Respiratory, Ophthalmology, and Neuroscience. Established robust planning and tracking frameworks to optimize cross-functional workstreams and accelerate development timelines.
Product Launch Manager, Pharmaceutical - Cosentyx (PsO, PsA, AS)Utibron, Seebri, Xolair, Fevipiprant, Kesimpta Responsible for cross functional team management in planning, developing and executing the commercialization of New Drug to market within the Pharmaceutical Sector. Experience developing Key Opinion Leader Programs and working on marketing campaigns is required. Master Planning, Strong Leadership and Direction, Client Relationship Management, Internal & External Alignment, Resource Management, Financial & Budget Management, Communication & Formal Communication Planning, Process Orientation, PMO Experience, Methodology & Frameworks, Operational & Long Term Thinking, Risk Management
• Managed Cross functional groups in the planning and execution of a Global System upgrade for Win 7 / Office 2010 for ETAS. • Developed interdepartmental and cross functional procedure to support the global rollout/upgrade • Develop, Managed and Conducted training sessions for SME’s to provide to end users • Responsible for all MCC global software application compatibility testing and validation. • Lead the MCC global implementation of NGWAC (Next Gen Web Audio Conferencing). • Managed Global migration of over 300 SharePoint 2007 to SharePoint 2010 team web sites • Responsible for Business Impact Analysis (BIA), Disaster Recovery (DR) Planning and Compliance to corporate, FDA and SOX regulations that are applicable for all Merck Pharmaceutical Applications. • Responsible for global business continuity planning and risk mitigation processes • Responsible for global scheduling and resource allocation planning • Coordinated a cross-functional team that included business owners, technical resources and compliance.
• Program Manager for New Product Development and New Technology Development for Orthopaedic Medical Devices, including Shoulder, Hip, Knee Cranial implants and Cements. • Managed full project lifecycle following QSR 820.30 guidelines from inception to commercial launch. This included interfacing with all key cross functional business units such as Product Development, R&D Engineering, Reliability Engineering, Advanced Operations, Marketing, Sales, Regulatory, Clinical, Sterility, Quality Assurance, Manufacturing, and Packaging. • Managed and updated project plans utilizing MS Project Server. • Compile all necessary project documentation in a DHF and eDHF (Design History File) repository for FDA Quality Audits and future use. • Ensure all change management procedures were following through Project lifecycle. • Collaborate with President and Senior Leadership on Strategic initiatives • Identified and implemented improvements to the New Product Development Process (NPDP) and actively developed training programs for personnel. • Spearheaded process improvement projects: Financial Tracking/Earned Value and Root Cause Analysis. • Provided periodic updates and presentations to Senior Management. • Revised SOPs to align with the FDA QSR 820.30 Federal Guidelines. • Collected and reported on key operational metrics.
• Managed 7-9 retail sales and engineering projects that encompassed mobile device application deployments and micro and macro cell site installation. • Responsible for managing and tracking project plan, time line, costs, resource allocation and risk management. Ensured all customer requirements were defined and met. • Provided technical assistance and issue resolution for various stakeholders and served as the liaison between development teams and the external clients. • Worked closely with senior business managers to ensure projects are meeting business objectives.