- Successfully managed companion diagnostic projects for phase 1-3 clinical trials for multiple assets with final submission and approval for one asset (timelines, budget, contracting, strategy development, implementation, submission, communication, partner / CRO management) and worked closely with external partners and internal stakeholders such as CDx leads, clinical development and operation, regulatory, biostatistcs, biospecimen, data management, procurement, legal, medical affair, commercial. - Played dual roles of CDx project manager and CDx lead due to a few programs needs

Oncology Precision Medicine, Alliance management (2017-2021)- Managed external collaborations in support of biomarker assay and clinical trial assay development and transfer for late phase clinical trial. Managed joint project team (JPT) and ensured on time delivery of assay development / validation, assay transfer, clinical sample testing and submission.- Managed external research collaborations and contract establishment for assay platform evaluation, assay development and validation and preclinical MoA study. Collaborated with external partners (academia and industry), program leads, legal and procurement to execute contract and deliver milestones specified in the contract.- Drove operational excellence: enhanced collaboration among internal stakeholders such as research, development and subsidiary CLIA lab. Developed and implemented tools that improve biomarker assay monitoring and assay selection.Oncology Precision Medicine, Clinical biomarker and companion diagnostics development (2011-2017)- Oversaw external clinical trial assay (CTA) and companion diagnostic assay (CDx) development and submission; led effort in setting up assay internally and providing proficiency panel, accuracy panels and screened commercial samples in support of external development.- Contributed to multiple internal CTA and CDx assay development and regulatory filing for programs in solid tumor, hematology and general medicine - Experienced in biomarker development and assay platform identification for CRC program.- Performed technical assessment on biomarker assay before being implemented in the clinical trial.- Rotation in QA: QMS update, author of a trial monitoring plan.- Two Vision Awards.

Medical device and diagnostic test development and new technology building block development. Four new product developments with one successful launch. Four US patents.Additional ExperienceROCHE DIAGNOSTICS CORPORATION, Indianapolis, INResearch Scientist - Research and DevelopmentPerformed immunoassay development for use in Roche Diagnostics' automated Hitachi and Integra hospital / central lab analyzers, reagent characterization, stability investigation, and new technology identification and evaluation.