David Chi Email & Phone Number

Waltham, MA, US

• Achieved organizational commitment for an IVD/CDx assay program and supported a cross-functional team through initiation, feasibility, and development phases of the product commercialization process.
• Researched market trends and conducted VOC to complete business plan, financial model, and customer requirements; as well as created key selling messages for commercial teams.
• Drafted Pharma CDx contract deliverables for a supplemental PMA development program that resulted in execution of a $10M project.

Waltham, MA, US

• Managed Pharma sponsored project of a custom NGS assay for immunotherapy application that achieved milestone revenue of $4.5M across a 10-month timeframe.
• Completed first project milestone ahead of schedule by working with management to find incremental resources and equipment to accelerate feasibility activities.
• Coordinated efforts with internal clinical lab for testing of 400+ fresh frozen NSCLC samples using a qPCR-based assay to help validate Pharma’s biomarker hypothesis.

Waltham, MA, US

• Completed six service contracts with Pharma that accounted for more than $1M revenue, which involved coordination of sample processing, resource allocation, and data reporting.
• Managed 2 CLIA/CAP validation projects: 1) comprehensive NGS assay for a Japanese national screening study with over $2M service revenue, and 2) commercial lung cancer NGS test used for over 1500 patients.
• Coordinated laboratory support of internal development projects which included sample management, equipment installation, and resource allocation.

St. Paul, Minnesota, US

• Managed supplemental PMA program for a commercially available cardiac ablation generator, consisting of a cross-functional team across multiple geographical locations.
• Navigated team through phase gate process, ensuring planning, development, V&V, manufacturing, and regulatory activities were completed within resource, budget, and time expectations.
• Presented monthly program status to senior management by highlighting key performance metrics, risks, and mitigation plans.

St. Paul, Minnesota, US

• Developed customer requirements for an updated cardiac ablation generator by conducting VOC research; including conference surveys and on-site lab observations.
• Launched two software upgrades by training sales force, updating collateral material, and managing launch inventories.

St. Paul, Minnesota, US

• Designed and developed an electrophysiology catheter for treatment of arrythmias.

Master Of Business Administration (M.B.A.), Business Administration And Management, General

Bachelor'S Degree, Chemical Engineering