Manager, Biomarker Operations

BioNTech SE

BOS Manager overseeing biomarker operations across Phase I–IV clinical trials at BioNTech. Coordinating teams, ensuring compliance, and delivering high-quality outputs for complex studies.

Posted 7/9/2026full-timeShanghai • 🇨🇳 ChinaMid-LevelSeniorWebsite

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

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development
Bonuses
Stock options

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical Sample TrackingBiomarker ManagementSample ReconciliationRegulatory ComplianceData Quality AssuranceOperational OversightRisk ManagementBudgeting for Biomarker CostsProcess Improvement ImplementationSOP Development

Soft Skills

Strong Communication SkillsOrganizational SkillsProblem-Solving SkillsAttention to DetailProactive Approach

Certifications

GCP CertificateCET-4