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:
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:
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.
Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.
BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.
BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.
Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html
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