Experience

DiaCarta, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• VP, Clinical Affairs

  • Feb 2022 - Present



Guardant Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Director, Clinical Diagnostics

  • Jun 2020 - Sep 2021

  Responsible for planning and execution of development and validation strategies of new product introductions and clinical trial management; Develop creative but realistic approaches to LDT and IVD development programs and lead clinical efforts to secure regulatory approvals;



Predicine

• United States
• Biotechnology Research
• 1 - 100 Employee

• Sr. Director of Operations and Product Development, Clinical Laboratory Director

  • 2017 - Jun 2020

  Led, developed and streamlined internal processes and resources to meet timeline, budget and revenue target, while satisfy the quality requirements from regulatory agencies and customers: • Led and sustained productivity and quality for international CAP lab • Managed multifunctional, international teams, including Clinical, lab Ops, Supply chain, Product Development staff



Life Technologies

• United States
• Biotechnology Research
• 700 & Above Employee

• Sr Manager

  • 2012 - 2017

  Lead the development of IVD companion tests and custom assays for use in clinical diagnostics and Public Health laboratories using NGS & PCR/qPCR. Develop/manage R&D staff and teams in matrix environment - Managed R&D teams (12 scientists), coordinated with Core Team and other functions, consistently and successfully meeting Pharma partners’ aggressive timeline and deliverables, resulted in multi-year, multi-million dollar revenue for the business - Developed and delivered novel Oncology… Show more Lead the development of IVD companion tests and custom assays for use in clinical diagnostics and Public Health laboratories using NGS & PCR/qPCR. Develop/manage R&D staff and teams in matrix environment - Managed R&D teams (12 scientists), coordinated with Core Team and other functions, consistently and successfully meeting Pharma partners’ aggressive timeline and deliverables, resulted in multi-year, multi-million dollar revenue for the business - Developed and delivered novel Oncology and Infectious Disease Assays following Product Development Process, also include CRO recruitment, clinical trial planning, site training and data reviews for necessary Regulatory submissions. - Collaborated and interfaced with other departments and functions (Marketing, Business Development, Regulatory, Technical Service and Operations) for proposal submission, landed multiple CDx/CTA/LDT/Feasibility contracts for the division - Negotiated and aligned drug/diagnostic activities and timelines, to develop IVD Assays under QSR Design Control to meet FDA, CE-IVD and other Regulatory requirements. - Provided guidance and technical expertise to divisional Business Leaders and Product Management teams, evaluating product pipeline and technology scouting - Planned and managed the department resources and budget - Authored on 1 patent application Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Lead Scientist (Scientist II)

  • Mar 2010 - 2012

  Led and managed internal teams and external collaborators, focusing on sample preparation, target enrichment and assay chemistry. - Sample Prep and Enrichment Team Lead: Managed 4-5 scientists and resources, developing and optimizing procedures for non-invasive prenatal diagnostics. - Managed Academia and Industrial Collaborations: Defined project scope, timeline and deliverables; negotiated contract; and summarized data and final report; provide technical assessment and Go-No Go decision… Show more Led and managed internal teams and external collaborators, focusing on sample preparation, target enrichment and assay chemistry. - Sample Prep and Enrichment Team Lead: Managed 4-5 scientists and resources, developing and optimizing procedures for non-invasive prenatal diagnostics. - Managed Academia and Industrial Collaborations: Defined project scope, timeline and deliverables; negotiated contract; and summarized data and final report; provide technical assessment and Go-No Go decision to upper management. - Led and co-led assay chemistry teams utilizing digital PCR chemistry. - Monitored the competitive landscape, exploring and evaluating new technologies. - Authored on 12 invention disclosures, and 1 peer-reviewed publication Show less



Siemens Healthcare

• Sr. Manager/Staff Scientist

  • 2002 - 2010

  Team Lead - HCV assay development / Head of Molecular Core facility: - Led and managed a team of scientists developing and optimizing nucleic acid diagnostic assays based on real-time RT-PCR technologies - Led the development and production of control and reference reagents used in IVD assays - Actively participated and built successful relationship with the multi-disciplinary project team consisting of Project Management, R&D, Marketing, Instrumentation, Regulatory, Operations… Show more Team Lead - HCV assay development / Head of Molecular Core facility: - Led and managed a team of scientists developing and optimizing nucleic acid diagnostic assays based on real-time RT-PCR technologies - Led the development and production of control and reference reagents used in IVD assays - Actively participated and built successful relationship with the multi-disciplinary project team consisting of Project Management, R&D, Marketing, Instrumentation, Regulatory, Operations, Quality - Member of cross-functional team, that identified and evaluated new opportunities pertinent to the current and future business needs, and provided technical expertise to the management Show less