Holly Lin

About Holly Lin

Result oriented and highly motivated biopharmaceutical professional with extensive experience in biomarker operations, bioanalytical function, vendor management, assay development, validation, implementation & outsourcing in GMP/GLP/GCP setting. Proven leadership and collaboration with cross functional team and external CROs in support of clinical and translational research.Clinical Sample ManagementDirected the overall operations for the clinical sample management group. Implemented and maintained an end-to-end process for clinical sample management across internal functional groups and external vendors. Management of Biomarker Operation: • Lead a team of associates to implement biomarker operations supporting phase clinical studies across multiple therapeutic areas, including Oncology, Inflammation, Liver Disease and HIV.• Demonstrated ability to effectively manage the biomarker activities in multiple, concurrent, global studies and programs of the highest complexity; Fully accountable for planning, feasibility assessment, timeline, resourcing and budget; Strong liaison between biomarker science and clinical operations.• Extensive experience in selection of CROs, assessment of vendors, development of RFP, MSA, SOW, negotiation of contracts, and management of external resources. • Accountable for biomarker sample collection, processing, analysis, storage and data transfer.• Initiated and led departmental process improvement initiatives; Generated best practice work instructions and guidelines to improve operational efficiency; Contributed to the development of study protocols, ICF, SOPs, CSRs, biomarker analysis plan and other documents.Management of Bioanalytical Function: • Managed bioanalytical method development, validation and life cycle maintenance in house or with CROs. • Led a diverse group of scientists to develop, validate and transfer complex biological methods in GMP/GLP environment.• Coordinate PK, PD, ADA and biomarker sample analysis for clinical and non-clinical studies.• Contributed to the development & review of clinical protocols/reports and CMC & bioanalytical sections in regulatory filings.

Experience

1. Director, Biomarker Operations

   Annexon Biosciences

   Nov 2021 — Present · San Francisco, CA, US

Education

• The University of British Columbia

  Doctor of Philosophy (PhD), Biology, General

• The University of British Columbia

  Master of Science (MS), Biology, General

• Zhejiang University

  Bachelor of Science (BS), Biomedical/Medical Engineering