General Description

We are seeking a highly motivated and detail-oriented Biomarker Research Associate to join our Translational Science team. This is a key opportunity to be part of a highly collaborative, science-driven team working on transformative programs like EBC-129, while gaining deep exposure to biomarker-driven clinical development. This role will primarily focus on supporting biomarker-related clinical trial operations, clinical biomarker analyses, strategic portfolio development, performing laboratory-based sample analyses, biomarker assay development, and preparation of reports and documentation, ensuring uninterrupted execution of our clinical programs and biomarker initiatives. Your contributions will directly support decision-making in early-phase trials and help advance our broader research portfolio.

Job Description

Key responsibilities include, but are not limited to:

• Assist in biomarker related clinical operations and oversee outsourced biomarker analyses with external CROs. Work closely with clinical operations team/ADL/CROs in biomarker sample tracking vs EDC reported information (data reconciliation), consent review (if required), setting up/provide input in biomarker analyses workflow e.g., EDC, IRT, DTS/DRA, CSR, sample labelling, etc.
• Aid the design and execute experiments for the development and validation of biomarker assays to be implemented in the clinic. Support writing/review and maintenance related SOPs/WIs/Lab Manuals, assay validation plans and reports, publications, worksheets, summary of QC/data results and record in ELN or preclinical reports.
• Perform pharmacodynamic (PD) analyses of clinical samples: PD analyses of clinical samples (e.g., hair follicles and tumour) via RT-qPCR or protein-based methods (mostly Western blot or IHC), including all required documentation for clinical sample analysis in compliance with regulatory requirements. Support in writing/review PD reports.  
• Develop and perform lab assays with preclinical samples (cell lines and/or tissue/serum from in vivo studies) to determine PK/PD correlations and biomarker analyses in efficacy studies. Join team discussions around planning and design of related in vivo pharmacology studies.
• Handling and managing of clinical samples in compliance with HBRA requirements and EDDC internal SOPs. Provide support in audit preparation, QC all incoming clinical samples to ensure compliance e.g., correct sample labelling, correct sample collection, shipping conditions, accurate requisition forms, etc, work closely with clinical operations team, CRO, and clinical trial sites in clinical sample handling and report any non-compliance found to the clinical team. 
• Supervise lab equipment maintenance and file documents e.g., calibration reports, data sheets, DO/invoices, service contracts, etc. Support in writing/review procurement/service contract documents (if required).
• Monitor and maintain inventory of laboratory reagents, consumables, and supplies to ensure uninterrupted workflow, timely procurement, quality and expiry verification, and accurate record-keeping. Maintain a clean, organised, and compliant laboratory environment through proper storage, routine housekeeping, and adherence to safety and waste disposal standards. Manage preclinical and clinical samples by accurately logging, labelling, and tracking their storage and movement in internal systems, ensuring sample integrity, traceability, and audit readiness. 
• Attend IBC safety meeting whenever required on behalf of the team.
• Handle clinical packing supplies and shipment coordination. Plan, track, and coordinate biomarker clinical supplies shipment to clinical trial sites (including preparation and provision of the supplies kit).
• Provide training (on-site/online) for clinical trial sites in biomarker sample handling. Assist site-lab management activities (resolution of issues), laboratory related protocol deviation review, CAPA (process improvement) and retraining.
• Assist in A*STAR IRB document management and application writing. Work closely with clinical operations and HBR officers to ensure proper maintenance of file folders and documentation for audits. 
• Perform ITQ for outsourced activities. Scope development, vendor sourcing, and quotation evaluation. Oversee outsourced activities to ensure timely, compliant deliverables, and support vendor qualification through audits with QA and documentation.

Job Requirements