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Biomarker Operations Lead

Exciting opportunity to advance Personalized Medicine using Biomarkers and Companion Diagnostics at an innovative biotech company

 

As the Biomarker Operations Lead at Symphogen, you will be responsible for the implementation of Biomarkers and Companion Diagnostics across Symphogen’s clinical programs. Additionally, you will be the clinical trial management point of contact in the collaboration with the biomarker team at Translational Medicine/Clinical Development.

Your main tasks are:

  • Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarkers (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 the biomarker strategy
  • Responsible for the identification and selection of Biomarker vendors in collaboration with the 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.

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 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.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Client Manager Gert Vium Andersen, Unique Human Capital on M: +45 42 95 08 83. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
/ /
cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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