Clinical Biomarkers Specialist
3 weeks ago
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 critical role in developing and validating biomarker assays for clinical trials.
Your Key Responsibilities
- Lead the development and validation of biomarker assays in a regulatory environment, working closely with internal stakeholders to ensure effective project execution.
- Collaborate with biomarker leads to align on assay requirements and serve as the primary point of contact for interactions with CROs.
- Provide technical and strategic input to programs as needed.
- Represent Lundbeck in interactions with CROs, conferences, and site audits.
- Evaluate and implement new technologies as needed.
About Our Team
The Clinical Biomarkers team is led by the Head of Clinical Biomarkers and consists of 7 team members with expertise in both fluid and imaging biomarkers. We collaborate across specialties to support clinical trials and work closely with our colleagues in Research.
What We're Looking For
- A Master's degree or PhD with 10+ years of experience in a similar role from pharma, biotech, or CRO.
- Expertise in developing, validating, and troubleshooting bioanalytical methods for large and small molecules using various analytical techniques.
- Experience in outsourcing and supervising assay development and bioanalysis of small molecules and biologics to CROs, as well as some bioanalytical operational experience.
- Working knowledge of regulatory requirements, including 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.
Join Our Community
Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability, and adaptability enable us to transform lives. We're committed to building a diverse workforce that reflects the people we serve.
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