Holly Lin
About Holly Lin
Holly Lin is the Associate Director of Biomarker Operations at BeiGene, overseeing clinical sample management and biomarker operations for various therapeutic areas in the San Francisco Bay Area.
Title
Holly Lin serves as the Associate Director of Biomarker Operations at BeiGene, based in the San Francisco Bay Area.
Company
BeiGene is a global, commercial-stage biotechnology company focused on molecularly targeted and immuno-oncology drug development. Holly Lin plays a pivotal role at BeiGene, guiding biomarker operations.
Directed Clinical Sample Management
At BeiGene, Holly Lin directs the overall operations for the clinical sample management group. She has been instrumental in implementing and maintaining an end-to-end process for clinical sample management across internal functional groups and external vendors.
Led Biomarker Operations for Phase I-III Studies
Holly Lin leads a team of associates to implement biomarker operations supporting phase I-III clinical studies across multiple therapeutic areas, including Oncology, Inflammation, Liver Disease, and HIV. She is accountable for the planning, feasibility assessment, timeline, resourcing, and budgeting of biomarker activities in global studies of high complexity.
Extensive Vendor and CRO Management Experience
Holly Lin has extensive experience in the selection of CROs, vendor assessment, development of RFP, MSA, SOW, negotiation of contracts, and management of external resources. She is accountable for biomarker sample collection, processing, analysis, storage, and data transfer.
Process Improvement Initiatives
Holly Lin initiated and led departmental process improvement initiatives, generating best practice work instructions and guidelines to improve operational efficiency. She has significantly contributed to the development of study protocols, ICF, SOPs, CSRs, biomarker analysis plans, and other key documents.
Bioanalytical Method Development and Validation
She manages bioanalytical method development, validation, and life cycle maintenance in-house or with CROs. Holly Lin leads a diverse group of scientists to develop, validate, and transfer complex biological methods in a GMP/GLP environment, overseeing PK, PD, ADA, and biomarker sample analysis for clinical and non-clinical studies.
Contribution to Regulatory Filings
Holly Lin has contributed to the development and review of clinical protocols/reports, as well as CMC & bioanalytical sections in regulatory filings, ensuring compliance and accuracy in submissions.