(Senior) Manager, Biomarker Operations
Shanghai, China | full time | Job ID: 11390
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:
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Execute the biomarker strategy by planning, coordinating, and overseeing biomarker sample operations throughout Phase I–IV clinical trials.
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Ensure biomarker sample collection, tracking, storage, and handling are performed in compliance with the clinical trial protocol and informed consent.
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Coordinate and integrate biomarker operational activities across cross‑functional teams.
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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
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Coordinate end‑to‑end HGR submission activities across study teams, sites, and cross‑functional stakeholders, managing timelines, dependencies, and submission quality.
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Provide operational oversight and risk awareness for HGRAC activities to support timely approvals and minimize regulatory impact on study milestones.
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Deliver biomarker operational outputs on time and with high quality, in compliance with ICH/GCP requirements.
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Establish and manage efficient biomarker sample logistics from study start‑up through data delivery and study close‑out.
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Set up and maintain accurate tracking, reporting, and metrics for biomarker samples and related data.
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Support internal teams in the selection, contracting, and qualification of biomarker vendors and central laboratories.
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Oversee day‑to‑day biomarker vendor activities, including performance monitoring, issue management, and escalation.
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Provide sample forecasts to support resource planning and cost estimation.
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Track and manage external biomarker‑related costs for budgeting purposes.
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Oversee biomarker sample operations for complex, multi‑region studies.
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Take accountability for biomarker operational deliverables, study milestones, and program objectives.
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Contribute to or author biomarker and laboratory manuals and other relevant documentation.
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Partner with Translational Science, Clinical Operations, and other functions to identify gaps and drive process improvements.
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Support the implementation of new or improved processes, including SOPs and guidance documents.
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Act as the primary liaison with internal laboratories to ensure effective communication and information flow.
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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
- CET-4.Click or tap here to enter text.
- 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 and remuneration:
If the position is filled in the US, the Expected Pay Range is XXX,XXX/year to XXX,XXX/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
Compensation at other locations may vary significantly.
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. 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.
We are looking forward receiving your application.