Stephen Su Email & Phone Number

Sunnyvale, Ca, Us

- Ensure clinical studies are properly resourced, conducted in compliance with regulatory requirements, and executed within budget and in accordance with established timelines.- Develop and maintain all study-related documents (e.g., Monitoring Plan, Laboratory Manual, Clinical Site SOPs, IRB Study Protocols, and CRFs).- Evaluate data quality and study progress on an ongoing basis, and work cross functionally with external and internal stakeholders to ensure timely completion of study milestones.- Oversee the selection, training and management of PIs, clinical sites, vendors and consultants.- Lead the development and maintenance of the Quality Management System and departmental QMS SOPs in accordance with designated regulatory standards (i.e. ISO 13485, 21 CFR 820).- Initiate and monitor QC programs for the department and manage the CAPA and continuous improvement system.- Assist with CLIA and CAP accreditation and subsequent routine audits.

Sunnyvale, Ca, Us

- Manage portfolio of clinical tests which include: multi-cancer hereditary risk panel, blood test for colorectal cancer screening and liquid biopsy for targeted therapy selection.- Envision and gather requirements from experience and internal/external stakeholders to develop product roadmaps and translate them into detailed requirements, key deliverables and successful launches/updates of clinical products globally (USA, Europe, Asia, and India).- Create and implement innovative marketing programs, pricing strategies and communications materials targeted to a global audience of oncologists, physicians and patients to drive clinical adoption.- Provide live training seminars and product presentations.

Milpitas, Ca, Us

- Implement the commercialization of new products and services.- Provide cross-functional support for partners and internal company functions including operations, sales and marketing, product management, technical support and R&D.- Responsible for all strategic and tactical marketing activities for both bioscience and chemical divisions with five direct reports.

Glebe, Nsw, Australia, Au

- Identify opportunities in which the introduction of Dx and personalized medicine solutions can provide competitive advantage or life-cycle management for in-market products.- Support commercialization and market introduction of Bio-Link's portfolio of companion diagnostic/diagnostic solutions including commercial vendor selection, contracting, pricing, reimbursement, global technology availability and alliance management.

- Performed genotoxicity assays (Ames, mouse lymphoma, micronucleus) under cGLP to assess potential mutagenic and carcinogenic effects of new chemical compounds.- Reviewed and reported preclinical data (pharmacokinetic studies, genotoxicity assays, and in vitro metabolism in hapatocytes).- Coordinated regularly with QC/QA department to ensure all assays conformed to global regulatory standards (EMA, TGA, FDA).- Drafted new and regularly update existing SOPs to ensure compliance with the latest cGLP guidelines.

Davis, California, Us

- Prepared DNA and protein samples for electrophoresis, enzyme analysis, PCR, ELISA, and MS-GC.- Qualified, calibrated, and carried out routine maintenance of laboratory equipment.

Doctorate, Biotechnology

Masters, Cell/Cellular And Molecular Biology

Bachelor Of Science, Microbiology