Biomarker Clinical Operations Lead (f/m/d)

We are looking for a new team member…

The Biomarker Clinical Operations Lead is responsible and accountable to provide biomarker operational expertise by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data, for global clinical studies.

Tasks & Responsibilities

• Provide biomarker operational expertise to clinical study teams to ensure operational feasibility and quality data delivery
• Be accountable for the development of the biomarker management plan and the execution of deliverables for assigned drug and device studies (e.g. IVD clinical performance studies) in partnership with the Clinical Study Lead or designee
• Manage all study level biomarker operations activities for both clinical (i.e. drug) and IVD studies (e.g. manage vendor/testing sites, ICF/protocol input, eTMF/RACT set-up, sample/data flow, data quality and transfer set-up)
• Partner with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, shipping conditions and logistics for biomarker samples
• Lead identification, selection and oversight of biomarker vendors, including development and oversight of scope of work, budget, ensuring quality delivery and performance
• Actively partner with Data Management to oversee and coordinate biomarker data format and delivery timelines
• Collaborate and partner with cross functional stakeholders (e.g. study team members, biomarker science, CDx, procurement, testing site monitors, diagnostic partners, central lab) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple study teams
• Provide technical knowledge of aspects related to biomarker analyses (e.g. sample collection and handling, assay, device and imaging technologies)
• Develop and oversee biomarker analysis timelines, budget, risk, compliance and quality, ensuring adherence to ICH/GCP, SOPs, ISO 20916 and regulatory requirements
• Attend operations team meetings and investigator/monitor meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and  companion diagnostic sample collection, handling and IVD procedures
• Provide responses to biomarker sample/IVD related questions or issues from Health Authorities

Profile

• Master’s or PhD degree in Life Sciences required
• Clinical operations experience, including work with global clinical study teams, is required
• Strong experience with vendor and project management
• Biomarker expertise is essential
• Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelines
• Have a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
• Experience working in a global and matrix environment
• Excellent collaboration, communication, influencing and presentation skills
• Flexibility, intercultural awareness, and eagerness to learn are essential
• Fluency in English with additional language skills as an asset

General Information

• Start date: as soon as possible (latest by November 2025)
• Duration: initially planned for 1 year (extension highly likely)
• Location: Basel
• Workload: 100% (up to 2 days/week remote work possible)

If you are interested in this opportunity, please send your CV in English.