Jing Lin

Program management for translational science and clinical science in developing radioligand therapeutics - Successful initiation of first-in-human clinical trial for LNTH-2403 (LRRC15) in Osteosarcoma. Contributed to clinical biomarker assay development for patient selection / exploratory purpose and implementation of the assay in the clinical trial - Managed / coordinated clinical protocol and report review and approval committee - Led clinical data visualization tool set up - Managed contract, timeline, deliverables etc.

- Managed / co-led CDx and clinical biomarker projects for multiple assets from phase 1-3. This includes 4 ADCs, 1 antibody and 1 small molecule (approved). Played dual roles of CDx lead and CDx project manager due to a few programs' needs. - Worked closely with external partners and internal stakeholders to drive Dx development and approval. This includes timeline, budget, deliverables, contracting, strategy and implementation, submission, communication with partner / CRO / central lab etc. - Facilitated seamless communication and transparency of project status throughout the organization by regularly updating progress dashboard / report and facilitating CDx program review and governance approval.

Oncology Precision Medicine, Alliance management - Managed external collaborations in support of biomarker assay and clinical trial assay development and transfer. 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, biomarker development 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 - Oversaw external clinical trial assay (CTA) and companion diagnostic assay (CDx) development and submission and contributed to the CDx strategy; 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. Additional experience - BAYER HEALTHCARE, Mishawaka, IN R&D. IVD development and new technology evaluation. 4 US patents. - ROCHE DIAGNOSTICS CORPORATION, Indianapolis, IN R&D. IVD development and new technology identification. Analytical method development and validation for medical devices.

Enzyme mechanism study

Reaction mechanisms of carcinogenic compounds in aqueous solution