David G. Kern, MBA

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
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
»» Innovative approaches to problem solving, leveraging a wide
range of skills, experience and
»» Strong leadership and interpersonal skills; proven ability to
bring diverse groups together to
tackle and resolve critical issues
Director, Program Management: Baseline Resource
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.
»» MBA: San Jose State University
»» Coursework in Project and
Portfolio Management, Alliance
Management, Risk Mitigation
»» Bachellor of Science: San Franscisco State University