Current title: Senior Director, Analytical R&D and Quality Control, Technical Operations CMC Current company: Mirati Therapeutics (since 2019). Mirati is a targeted oncology company that focuses on the development of cancer therapeutics. Mirati was acquired by Bristol Myers Squibb in January 2024. AREAS OF EXPERTISE • Strategic Leadership: Over 20 years leading a drug development function, with C-1 reporting experience. Proven ability to set direction, manage budgets (up to $5M external budget), and oversee geographically dispersed teams (US, Europe, Asia) in outsourced and in-house models. • Building Development Capabilities: Expertise in establishing and optimizing development laboratories and systems, leading and mentoring development teams (up to 25 employees). • Regulatory Expertise: Successful track record of navigating complex regulatory pathways and securing new drug approvals in major markets (US, EU, UK). INTRODUCTION A seasoned drug development leader with 25+ years of expertise in San Diego's biotech industry. I possess in-depth Chemistry, Manufacturing and Controls (CMC) knowledge across all phases, from pre-clinical to commercialization and lifecycle management, and a proven track record of leading cross-functional teams to deliver late-stage assets. CAREER HISTORY Over 20 years of experience in the San Diego biotech sector, leading a development function at multiple companies. Proven track record of building and optimizing development capabilities, driving successful regulatory approvals, and fostering strategic partnerships. Contributed to the approval of five novel pharmaceutical products. At Mirati, I spearheaded the creation and growth of the Analytical Development & Quality Control organization, enabling the accelerated development and approval of Krazati® (3 years from IND to NDA) and the broader oncology pipeline. This included transitioning from an outsourced development model to building robust in-house capabilities, co-developing a late-stage asset with BeiGene, and ensuring a smooth post-acquisition integration with Bristol Myers Squibb. Previously, I held leadership roles at Pacira Pharmaceuticals, Arena Pharmaceuticals (acquired by Pfizer), La Jolla Pharmaceuticals, and Alliance Pharmaceuticals.