David G. Kern, MBA Capabilities and Experience Work Experience Director: MyRAQA, Inc. 2009 - Present Team Lead on multiple 510(k) projects, stategic advisor on business development. Helping establish Program Management as core competency. Director, Project Management: XDx 2007 – 2008 Led XDx’ development projects in transplant and autoimmune programs. Created design control process for managing project development projects. Director, Project and Information Management: 2006 – 2007 NeuroMolecular (now Adamas) Pharmaceuticals Responsible for leading NeuroMolecular’s knowledge management activities. Was program leader through proof of concept (research) phase. Associate Director, Strategic Alliances 2001- 2006 Senior Manager, Corporate Development Affymetrix Oversight for all external relationships within the Molecular Diagnostics business unit, including negotiating amendments and managing milestone activities. Business lead on research and co-development collaborations. Led the product launch effort for the Human Genome U133 array. Experience Highlights »» More than 20 years of experience in product development and relationship management with biotechnology companies, both small and large. »» Track record of success in product launches, relationship management and business process optimization, including design control »» Innovative approaches to problem solving, leveraging a wide range of skills, experience and training »» Strong leadership and interpersonal skills; proven ability to bring diverse groups together to tackle and resolve critical issues Director, Program Management: Baseline Resource 2001 Consultant on Program and Project Management, including the establishment of product development and portfolio management systems. Program Manager, Project Management: Affymetrix 1998 – 2001 Managed several product development projects in both the gene expression and instrumentation programs. Member of business teams chartered with improving and implementing business processing within the organization. Project Manager: Chiron 1991 – 1998 Managed cross-functional development projects for both 2nd and 3rd generation HIV viral load tests. Major contributor on core team responsible for implementing design control process within business unit. About MyRAQA MyRAQA is a full-service IVD Regulatory consulting firm. Founded in 1998, MyRAQA has grown to include leading experts in RA, QA, Design Control, Process Development, Study Design, and Statistical Analysis. MyRAQA has worked on the full range of US and EU IVD applications, including PMAs, IDEs, 510(k)s, de novo 510(k)s and EU technical files. Education »» MBA: San Jose State University »» Coursework in Project and Portfolio Management, Alliance Management, Risk Mitigation »» Bachellor of Science: San Franscisco State University