Senior Manager, Biomarker Operations

BioNTech SE

(Senior) Manager, Biomarker Operations at BioNTech leading end-to-end biomarker operations for Phase I–IV clinical trials, ensuring high-quality, compliant delivery of biomarker samples and data.

Posted 5/25/2026full-timeShanghai • 🇨🇳 ChinaSeniorWebsite

ATS Keywords

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Hard Skills

biomarker sample operationsclinical trial protocol complianceHGR application documentssample trackingsample reconciliationanalytical methodsproject managementbiomarker operational activitiesdata quality managementregulatory compliance

Soft Skills

communication skillsorganizational skillsproblem-solving skillsattention to detailindependenceproactivitymentoringteam coordinationtime managementadaptability

Tools & Technologies

WordExcelPowerPointproject-tracking toolsSOPsguidance documents

Certifications & Qualifications

GCP certificateBachelor’s degree in Clinical MedicineBachelor’s degree in PharmacyBachelor’s degree in Life Sciences

Industry Keywords

clinical operationscentral laboratory operationsoncology studiesCROsbiotechpharmaceutical companiestranslational medicinediagnosticsbiomarker managementmulti-region studies

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

Bachelor’s degree or higher in Clinical Medicine, Pharmacy, Nurse, Life Sciences, or related fields.
GCP certificate is preferred.
CET-4.
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.

Benefits

Comp & perks

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 are determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.