SUMMARY:

• Project Manager/Portfolio Project Manager with significant experience in the healthcare and medical device research environment. Proven abilities to analyze business processes and markets; excellent leadership, project management, and team building skills. Strong understanding of both medical device and pharmaceutical product development processes (GCP), as well as CLIA.

PROFESSIONAL EXPERIENCE:

Confidential - San Diego, CA

Program Manager

Confidential is a genomics technology company. Serve as project manager for genomic test products, two software development projects (agile), one business unit acquisition, and two unit divestitures. Perform all standard project management functions: work with cross functional teams to develop project plans, monitor project team activities, and identify deviations from schedule, budget, or scope. Improved internal processes, including the conceptual design of HLI’s order to fulfillment process.

Confidential - San Diego, CA

Manager, Program Management Office

Millennium is a young entrepreneurial company that has established a dominant position in medication adherence testing. As manager of the PMO, responsibilities included the management of the Project Management Office, training and mentoring of new project managers, as well as the establishment of project portfolio management, and corporate governance processes. In addition, served as project manager for major company projects.

Confidential - Irvine, CA

Portfolio Project Manager

Managed portfolio of 26 surgical instrument research projects. All of these were products requiring IDE approval. Worked with engineering project team to develop project plans, update project management reporting tools, and monitor projects to ensure they tracked to schedule and budget. Managed the corporate governance process. Worked with cross-functional teams to develop product development plans, budgets and timing (milestones). Provided comprehensive planning and tracking support for Project Team using Enterprise Project Portfolio Management software (Planisware Navigator). Integrated program specific requirements into the resource planning models and financial systems.

Confidential - San Diego, CA

Sr. Clinical Research Project Manager/Department Manager, Oncology Research

Project Manager for the KP Adult and Pediatric Oncology Clinical Research program for all of Southern California. Supervised 44 research nurses and research associates, two research pharmacists, and regulatory and office staff. On average, 35-40 protocols were open at any given time at 13 different sites. Financial Management of department $4.5M dollar budget included development of annual budgets, pharmaceutical contract budgeting and negotiation. Responsible for on-going development of departmental SOPs, and compliance with GCP, FDA regulations, and research protocols. Primary interface with Pharmaceutical companies, IRB and Kaiser Compliance. Managed the implementation of the Imedris clinical trials management system and participated in developing research department work flows for Health Connect (EPIC). Created IRB-approved patient recruitment brochures in multiple languages, managed patient recruitment efforts at all sites. Program won ASCO 2008 Clinical Participation Award.Education & Training Associates - Poway, CA 2003 - present

Confidential, San Diego

Director, Program and Research Development

• Principal architect of strategic and tactical plans for product, marketing, service and systems to meet annual revenue and operating income goals. Results:
• Increased enrollments to 12,000 annually.
• Achieved revenue growth from $1.25M/year to $6.5 M/year, over 400%.
• Increased Net Revenue to 38% ($2.5M).
• Named UCSD Extension Department of the Year in 1998.
• Largest revenue and the largest net contributor in UCSD Extension history.
• Researched and presented business plan to develop an in-house Distance Learning Group at UCSD Extension. Led team effort, co-authored winning proposal for a $130K grant from NTIA, exceeding planned revenue targets. The DL business unit now generates $500K annually -- producing positive income generation 1 year ahead of schedule.
• Completely revamped program -- developed over 30 new Certificate Programs, hundreds of courses.
• Invited contributor to S.D. Workforce Partnership Annual Workforce study: San Diego's Software and Computer Services Industry Cluster: A Strategic Workforce Development Plan 2001-2003.
• Developed and maintained positive business relationships with a number of industry and academic organizations, establishing Joint Venture Educational Alliances with SAIC, Mira Costa Community College, SSQA, IEEE, AEA, and the UCSD School of Engineering.

Confidential, Berkeley - Berkeley, CA

Continuing Education SpecialistS)

• Generated $2.9M in gross revenues FY 1994-1995. Berkeley Extension’s top producing CES.
• Created the concept and lead the team that developed and presented the 1993 Technology Summit with high-level UCB and Stanford faculty, tech industry CEO’s, and high-level government officials including: Vice President, Al Gore, Secretary of Defense, William Perry; Secretary of Commerce, Ron Brown.
• Team Leader to develop interactive video-based instruction under grant from Pacific Bell. Co-authored grant for $250K. Later, named team leader for U.C. Berkeley Extension effort, EXTEN, in new instructional technology, encompassing on-line instruction, video, CD-ROM, and Worldwide Web Delivery.

Confidential - Irvine, CA

Program Representative III

Planned, developed and administered short courses in the U.S. and Europe. Generated revenues in excess of $1M annually; expanded in-house revenues by a factor of 10. Member, Advisory Committee for the Competitive Manufacturing