Clinical Biomarkers Specialist

3 weeks ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time

Clinical Biomarkers Specialist

Are you a technical expert with experience in developing and validating biomarker assays for clinical trials? Do you thrive in a cross-functional environment, collaborating with stakeholders to drive innovation? This opportunity is ideal for you.

Your New Role

  • As a Clinical Biomarker Specialist, you will lead the development and validation of assays in a regulatory environment, working closely with internal stakeholders to ensure effective project execution.
  • You will work closely with the biomarker lead to align on assay requirements and serve as the primary point of contact when interacting with CROs to coordinate proposals, work orders, and bioanalytical processes.
  • You will provide technical and strategic input to programs as needed.
  • You will represent Lundbeck when interacting with CROs, attending conferences, and conducting site audits.
  • You will have the opportunity to evaluate and implement new technologies as needed.

Your Future Team

The Clinical Biomarkers team is led by the Head of Clinical Biomarkers, whom you will report directly to. We are a team of 7 members with expertise in both fluid and imaging biomarkers, collaborating across specialties to support clinical trials and with our colleagues in Research. The Clinical Biomarkers Department is part of Experimental Medicine within Global Clinical Development at Lundbeck.

What You Bring to the Team

To succeed in this role, you should have:

  • A MS +10 years or PhD +4 years of experience in a similar role from pharma, biotech, or CRO.
  • Expertise in developing, validating, and troubleshooting bioanalytical methods for both large and small molecules, using various analytical techniques such as immunoassays, genotyping, RNAseq, and LCMS methods.
  • Experience in outsourcing and supervising assay development and bioanalysis of small molecules and biologics to CROs, as well as some bioanalytical operational experience.
  • Evidence of working knowledge of regulatory requirements, including experience with GLP/GCP, and applying these regulations when writing study plans and reports.
  • A collaborative mindset and skilled in interpersonal interactions and stakeholder management.
  • Proficient in spoken and written English.

Lundbeck's Promise to You

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability, and adaptability enable us to transform lives. We want to go faster and further in addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at https://www.lundbeck.com/.

Apply Now

We want to hear from you. If you're unsure if you meet all the requirements, we still encourage you to apply. Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.

We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.



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