Project Management Lead

Extensive experience in product development, project, program, portfolio and change management within IVD, MedTech and Biopharma

Proven track record in navigating FDA and European medical device regulations, ensuring compliance and successful product launches

Well-versed in building up PMO structures from scratch and maturing PMO organizations

Expert in strategic planning and business case development, driving new product commercialization and market growth

Successful in leading and managing global programs, including PMA submissions, IVDR approvals, and large-scale government contracts

Strategic thinker, international background, gets things done, dependable, trustworthy, confident, and energetic

Established a company’s PMO

As Head of PMO and executive team member, reported to COO

Led a team of six global program managers

Formed the PMO supporting new product development and onmarket sustaining projects for multiplex autoimmune disease test systems, consumables, reagents, and software products

Presented mission, vision, and roadmap to company’s senior management to establish an enterprise-level Strategic Portfolio Management Office (SPMO)

Strengthened cross-functional collaboration, created and implemented IVDR, ISO 13485, ISO 14971, and 21 CFR Part 820- compliant design control processes, and implemented a standardized governance structure to improve project prioritization, avoid delays, prevent revenue loss, and enhance business value

As Director and PMO executive team member, supported PMO setup and led multiple, business-critical clinical programs

Reported to VP of Program Management Office and General Manager of Clinical Platform

Partnered with global CROs, developed and launched cGMP antibodies for cell therapy applications

Managed company’s clinical reagents portfolio

Directed Leukemia & Lymphoma and Multiple Myeloma MRD programs

Received IVDR approval for multiple flow-cytometry based L&L assays and launched products successfully in the European market with 2-digit growth rates

As Program Director of company’s Companion Diagnostics initiative, provided program & resource management, business development, and biopharma partnering support

As Business Integration Lead, managed all company business integration-related activities

Provided strategic consulting and business management support to local site and company network

Reported to Head of Strategic Planning & Portfolio Management

Provided strategic consulting and business management support

Oversaw and managed a portfolio of activities related to key site programs including strategy and goal setting, site resource management, portfolio management, project business case development, and launch capability program support

Led two global work streams to drive the completion of a detailed plan for implementation and realization of Manufacturing Science & Technology (MSAT) improvements across 21 global manufacturing sites

Responsible for project management, change management and communication

As one of the directors of company’s PMO, supported the company’s Oncology Business Unit

Had three direct reports and reported to SVP of Product Development

Led multiple clinical programs to develop NGS Oncology panels

Worked effectively with internal and external stakeholders to ensure program goals were in alignment with business objectives

Interacted with business partners, including Pharma partners and CROs to ensure that all contractual obligations were met

Adhered to company’s product development process (PDP) and FDA design control standards and regulations

Trained core teams on changes to the PDP process and FDA regulations

Acted as leader of cross functional core teams, internal expert in product commercialization process, IVD project management, and communication liaison with Business Unit Management

Led the PMA submission process for a companion diagnostics (CDx) program to develop a gene signature assay for lung and melanoma cancer patients

Supported multiple global programs to develop next-generation sequencing (NGS)-based tests for the oncology market in Europe

Managed two multi-million-dollar government contracts funded by the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DoD) to develop a qPCR-based quantitative biodosimetry assay and a rapid blood test for anthrax infection following an anthrax attack

Provided on-site leadership for global programs in the area of business process improvement and GMP optimization

Managed and improved company process of preparing drug dossiers in compliance with the Academy of Managed Care Pharmacy (AMCP) format for formulary submissions

Led two global work streams to drive the completion of a detailed plan for implementation and realization of Manufacturing Science & Technology (MSAT) improvements across over 20 global manufacturing sites

Responsible for project management, training, change management and communication

Contributed to IPM’s project management knowledge database and supported the onboarding, coaching and development of new staff

Served the life sciences, medical devices, in-vitro diagnostics, biotech, and biopharmaceuticals industries

Provided expertise and support in the area of strategic planning, market development, business development, product development, intellectual property valuation and IVD program management