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:
Ensure biomarker sample collection, tracking, storage, and handling are performed in compliance with the clinical trial protocol and informed consent.
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.
Oversee day‑to‑day biomarker vendor activities, including performance monitoring, issue management, and escalation.
- 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.
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BioNTech, the story
At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.
Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.
Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.
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