As a Biomarker Operations Lead, you will be responsible for ensuring operational implementation and execution of the Biomarker plan in clinical trials while securing biomarker data quality and providing biomarker operational expertise and guidance to all relevant internal and external stakeholders.
With direct report to Director Biomarker Operations, Servier.
Your main tasks are:
- Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker (including companion diagnostic (CDx)) in clinical studies: collection, processing, analysis, data receipt, and final sample disposal/repository
- Serve as the key biomarker operational contact with internal and external stakeholders, for successful implementation of biomarker strategy
- Responsible for the identification and selection of Biomarker vendors in collaboration with Purchasing department and in consultation with the Translational Medicine department – including a schedule of work, contract, and budget
- Responsible for the management and oversight of biomarker CROs from the study start-up to closeout and ensuring operational efficiency and quality of all deliverables including budget (invoice review & reconciliation)
- Contribute to and ensure the data integrity of clinical biomarkers/CDx:
- Ensure biomarker samples are collected in adherence to the highest standards of quality (ICH/GCP, SOPs), ethics, and informed consent
- Provide education and training for biomarkers sample collection and handling to clinical sites and clinical operation teams
Your qualifications are several years of experience in drug development from the pharmaceutical industry within biomarkers, preferably oncology. Moreover, you have a thorough knowledge of ICH/GCP, guidelines governing the conduct of clinical studies, and best practices for sample management.
It is an advantage if you have outsourcing management experience. Finally, clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples is an asset.
You have a Master’s Degree within a relevant scientific field.
You are a person who excels at prioritizing and managing time efficiently. You have critical reasoning skills including the identification and resolution of complex problems. Moreover, you are flexible and work at ease in a matrix organization and international teams. You have excellent interpersonal and communication skills and a high level of professionalism and respect, with a willingness to listen to and answer to customers’ expectations.
Symphogen offers a challenging and versatile job in an innovative, flexible, focused, and committed biotech environment. Moreover, they offer strong cross-functional teamwork, room for individual performance and development, and passionate, inspiring, and fun colleagues.
Domicile: Symphogen’s office in Ballerup.
Unique Human Capital is handling the recruitment. For more details about the job or the company, please contact Unique Human Capital, CEO Jørn Duhn on: email@example.com or Senior Research Consultant Elisabeth Haun on: firstname.lastname@example.org. All applications must be in English and are treated confidentially.
You can apply directly via this link: https://uhc.dk/en/available-jobs/biomarker-operations-lead/
Symphogen is a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology. We have a highly efficient antibody discovery and research platform supported by comprehensive early development capabilities.
Our antibody platform delivers antibodies with unique functionalities providing best or first in class potential as combination or mono therapy. Our approach and capabilities are well suited for combination therapies at the core of future cancer treatment.
Symphogen is located in Ballerup in the greater Copenhagen area. The company currently employs approximately 120 people