Expert Details
Pharmaceutical & Medical Device Program and Portfolio Management
ID: 740800
Indiana, USA
Expert currently serves as Executive Director of Portfolio and Program Management for a biotechnology company, overseeing enterprise-wide portfolio tracking and visualization systems and driving program management excellence. Prior to this, Expert held a similar executive leadership role at a global pharmaceutical company, where Expert was accountable for R&D governance, portfolio tracking, and communication of pipeline updates to board and executive leadership. Expert spent 14 years at a major global pharmaceutical company, most notably serving as Senior Director/Advisor and COO of a Diabetes Business Unit, where Expert led global development and operational delivery of a late-phase diabetes product platform, integrating marketing, medical, manufacturing, and regulatory functions into unified development plans supporting global registration, approval, and launch.
Earlier in Expert's career at the same organization, Expert held progressively responsible roles spanning CM&C and product launch project management, global procurement leadership, and pharmaceutical chemistry and quality systems, reflecting a technical foundation that complements Expert's program management expertise. Expert holds a Bachelor of Science in Chemistry from Illinois State University and a Master's in Project Management from ITT, along with certifications in regulatory affairs for pharmaceuticals and devices, Six Sigma Green Belt, and critical chain project management methodology. Expert has led numerous FDA interactions and presentations, and has deep experience implementing modern program management methodologies and enterprise-wide portfolio management tools and governance structures.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1997 | Degree: MBA | Subject: Business, Program Management | Institution: ITT |
| Year: 1989 | Degree: BS | Subject: Chemistry | Institution: Illinois State University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2024 to Present | Employer: Undisclosed | Title: Executive Director, Program and Portfolio Management | Department: |
Responsibilities:Accountable for the business process and associated tools providing near-real-time tracking and visualization of enterprise activities, enabling accurate project information for key stakeholder decision-making. Serves as product owner for portfolio management tools, overseeing backlog management, rollout, training, stakeholder management, and change management, and is accountable for program management discipline and execution excellence across the organization. |
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| Years | Employer | Title | Department |
| Years: 2022 to 2024 | Employer: Organon Pharmaceuticals | Title: Executive Director, Portfolio Management, Governance and Integration | Department: |
Responsibilities:Accountable for reliable, credible tracking and visualization of the research and development book of work, providing accurate project information to key stakeholders for decision-making. Facilitated technical, functional, and strategic governance bodies and associated business discussions supporting R&D decision-making, and was accountable for communicating pipeline updates to the Board of Directors and C-suite. Provided project leadership on key asset teams to enable delivery of milestones, and was accountable for onboarding, development, and culture-building for the portfolio and project management operations team. |
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| Years | Employer | Title | Department |
| Years: 1989 to 2022 | Employer: Eli Lilly & Company | Title: Sr. Director/Advisor, COO | Department: Diabetes Business Unit |
Responsibilities:Responsible for the global development and operational delivery of the company's late-phase (Phase III–IV) Diabetes Platform, translating marketing, medical, manufacturing, and regulatory requirements into a single integrated plan supporting global product registration, approval, launch, and life-cycle management. Developed and aligned multiple integrated clinical development strategies (scope, budget, timeline, and risk) in partnership with a major contract research organization, and was responsible for quality and organizational excellence across asset delivery teams, including cross-functional process performance, alliance management, and affiliate relationships. Led business process improvements in project management processes and tools, managed cross-functional and upward communication, provided integrated project budget and cost management, and designed and implemented streamlined cross-functional governance for development decisions. Served as a deep technical project management expert, evaluating and piloting innovative project management processes and tools.Other Roles: CM&C Project Manager, 2003–2008. Served as launch and commercialization project manager for small molecule products, covering bulk manufacture through packaging. Expert was accountable for raw material contingency planning, technical transfer of processes between manufacturing sites, regulatory submission of process changes, and new pharmaceutical site startups, and led development and implementation of product line extensions. Global Procurement Department Head, 1999–2003. Led a team of 20+ employees across multiple business areas, serving as project leader for multiple procurement infrastructure initiatives (including electronic invoicing, supplier portal, and contract management systems) and as business area liaison for implementation of a global ERP system. Accountable for development and implementation of spend management processes across organizational sectors. Global Product Launch Leader, 1997–1999. Defined, developed, and implemented the manufacturing and marketing launch of a new pharmaceutical product across two-thirds of served markets, and developed a departmental training and development program based on industry project management guidelines. • Pharmaceutical Chemist / Project Planner / Quality Systems Coordinator, 1989–1997. Conducted formulation studies supporting product registration, including physical characterization work, and optimized processing steps for developmental molecules. Expert redesigned the review and approval process for development SOPs and managed multiple teams implementing new processes and procedures for development activities. |
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Career Accomplishments
| Licenses / Certifications |
|---|
| • Regulatory Affairs Certificate in Pharmaceuticals and Devices, 2016 • Critical Chain Expert Certification, 2010 • Medical Transcription Specialist Certification, 2009 • Six Sigma Green Belt Certification, 2007 |