Manager, Biomarker Operations

Job description

Shanghai, China | full time | Job ID: 11746 About the role: The BOS Manager leads end‑to‑end biomarker operations across Phase I–IV clinical trials, ensuring compliant, high‑quality delivery of biomarker samples, data, and vendor activities for complex multi‑region studies. This role coordinates cross‑functional teams, oversees HGR submissions and regulatory risk, manages timelines and costs, and drives operational excellence to support study milestones and program objectives. Your contribution: ​ ​Execute the biomarker strategy by planning, coordinating, and overseeing biomarker sample operations throughout Phase I–IV clinical trials. ​Ensure biomarker sample collection, tracking, storage, and handling are performed in compliance with the clinical trial protocol and informed consent. ​Coordinate and integrate biomarker operational activities across cross‑functional teams. ​Lead the preparation, review, and submission of HGR application documents, ensuring regulatory compliance and alignment with study requirements, as well as leading the activities of biosample exportation/importation per study requirements ​Coordinate end‑to‑end HGR submission activities across study teams, sites, and cross‑functional stakeholders, managing timelines, dependencies, and submission quality. ​Provide operational oversight and risk awareness for HGRAC activities to support timely approvals and minimize regulatory impact on study milestones. ​Deliver biomarker operational outputs on time and with high quality, in compliance with ICH/GCP requirements. ​Establish and manage efficient biomarker sample logistics from study start‑up through data delivery and study close‑out. ​Set up and maintain accurate tracking, reporting, and metrics for biomarker samples and related data. ​Support internal teams in the selection, contracting, and qualification of biomarker vendors and central laboratories. ​Oversee day‑to‑day biomarker vendor activities, including performance monitoring, issue management, and escalation. ​Provide sample forecasts to support resource planning and cost estimation. ​Track and manage external biomarker‑related costs for budgeting purposes. ​Oversee biomarker sample operations for complex, multi‑region studies. ​Take accountability for biomarker operational deliverables, study milestones, and program objectives. ​Contribute to or author biomarker and laboratory manuals and other relevant documentation. ​Partner with Translational Science, Clinical Operations, and other functions to identify gaps and drive process improvements. ​Support the implementation of new or improved processes, including SOPs and guidance documents. ​Act as the primary liaison with internal laboratories to ensure effective communication and information flow. ​Provide mentoring and support to new hires. A good match: ​​Bachelor’s degree or higher in Clinical Medicine, Pharmacy, Nurse, Life Sciences, or related fields. ​GCP certificate is preferred. ​​At least 3 years of experience in clinical operations or central laboratory operations, including clinical sample tracking/management (e.g., biomarker, PK/PD samples), sample reconciliation, and/or HGR management. ​Solid understanding of analytical methods used in oncology studies. ​Demonstrated experience contributing independently to global (regional) clinical studies, gained through roles in CROs, biotech/pharmaceutical companies, and/or central laboratories.​ ​​Strong written and verbal communication skills, with good English proficiency for working with global and cross‑functional teams. ​Experience in project or operational management, preferably in biomarker, translational medicine, diagnostics, or clinical laboratory settings. ​Proficient in standard office tools (Word, Excel, PowerPoint) and basic project‑tracking tools. ​Able to take ownership of biomarker operational activities, including planning, coordination, and execution. ​Comfortable working in a fast‑paced environment and managing tasks under pressure. ​Experience working in matrix teams, coordinating with Clinical Operations, Translational Medicine, vendors/CROs, and central laboratories. ​Some experience in coordinating or guiding team members or vendors. ​Able to identify and resolve operational issues related to biomarker sample handling, shipment, and analysis. ​Strong organizational and planning skills, with attention to timelines, data quality, and compliance. ​Proactive, independent, and detail‑oriented, with good problem‑solving skills. Your Benefits: Company Pension Scheme Childcare Jobticket Company Bike Special Vacation ... and much more. Apply now - We look forward to receiving your application! Apply to our Shanghai, China location by sending us your documents via our online form. For any questions, contact our talent acquisition team on + 49 (0) 6781 9855 220. Job ID 11746 (please always specify if you have any questions) By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter. Note for applications within Europe: Please note that if you wish to claim travel expenses incurred in connection with an in-person interview, we are obliged to carry out a sanctions list check*. This is carried out by our partner, HireRight. Travel expenses will only be reimbursed if this sanctions list check does not yield any matches. Reimbursement can be made provided that the check is successfully completed. * Your first name, surname and date of birth will be processed for the sanctions list check. The legal basis for carrying out the sanctions list check for positions at BioNTech in Europe is BioNTech’s legitimate interest. Please note that BioNTech will not carry out the sanctions list check if no travel expenses are to be reimbursed. If you do not give BioNTech your consent to the sanctions list check, your travel expenses cannot be reimbursed. This will not affect your application.