Clinical Biomarkers Specialist

1 month ago

Copenhagen, Copenhagen, Denmark Lundbeck Full time

Unlock Your Potential as a Clinical Biomarkers Specialist

Lundbeck is seeking a highly skilled Clinical Biomarkers Specialist to join our team in Valby, Denmark. As a key member of our Clinical Biomarkers team, you will play a crucial role in developing and validating biomarker assays for clinical trials.

Your Key Responsibilities

  • Lead the development and validation of assays in a regulatory environment, working closely with internal stakeholders to ensure effective project execution.
  • Work closely with biomarker lead to align on assay requirements and be the point of contact when interacting with CROs to coordinate proposals, work orders, support bioanalytical processes, etc.
  • Provide technical and strategic input to programs as needed.
  • Represent Lundbeck when interacting with CROs, attending conferences, etc., and conducting site audits.
  • Evaluate and bring in new technologies as needed.

About the Role

This is an exciting opportunity to join a dynamic team and contribute to the development of innovative biomarkers for clinical trials. As a Clinical Biomarkers Specialist, you will have the opportunity to work closely with cross-functional teams, including research, development, and regulatory affairs.

What We Offer

Lundbeck offers a competitive salary and benefits package, as well as opportunities for professional growth and development. Our team is passionate about making a difference in the lives of people living with brain disorders, and we are committed to creating a workplace that is inclusive, diverse, and supportive.

Requirements

  • 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 a variety of 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.
  • Collaborative mindset and skilled in interpersonal interactions and stakeholder management.
  • Proficient in spoken and written English.

How to Apply

If you are a motivated and experienced professional looking for a new challenge, please submit your CV and a brief statement outlining your motivation for applying. We look forward to hearing from you

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