(Senior) Manager, Biomarker Operations

Responsibilities

• Lead end-to-end biomarker operations across Phase I–IV clinical trials, ensuring compliant delivery of samples, data, and vendor activities.
• Execute biomarker strategy by planning and overseeing sample collection, tracking, storage, and handling in compliance with protocols.
• Lead the preparation, review, and submission of HGR application documents and manage biosample exportation/importation activities.
• Coordinate biomarker operational activities across cross-functional teams, managing timelines, dependencies, and regulatory risks.
• Oversee biomarker vendor activities, including selection, contracting, performance monitoring, and issue management.
• Establish and maintain accurate tracking, reporting, and metrics for biomarker samples and related data.
• Partner with Translational Science and Clinical Operations to drive process improvements and implement new SOPs.

Requirements

• Bachelor’s degree or higher in Life Sciences, Clinical Medicine, Pharmacy, Nursing, or a related field.
• At least 3 years of experience in clinical operations or central laboratory operations, including sample management (biomarker, PK/PD) and HGR management.
• Solid understanding of analytical methods used in oncology studies.
• Demonstrated experience contributing to global or regional clinical studies within a CRO, biotech, or pharmaceutical environment.
• Strong English proficiency for effective communication with global and cross-functional teams.
• Proficiency in standard office tools and project-tracking software.
• Ability to work independently in a fast-paced, matrixed environment.

Preferred Qualifications

• GCP certification.
• Experience in project or operational management within translational medicine or diagnostics.
• Experience coordinating or guiding team members and external vendors.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We focus on addressing high medical needs, such as cancer and infectious diseases, through innovation and a commitment to improving global health.