Senior Specialist – Clinical Biomarkers

Job title:

Senior Specialist – Clinical Biomarkers

Company

Lundbeck

Job description

Senior Specialist – Clinical BiomarkersDo you have a strong strategic and regulatory acumen with in-depth experience in developing and validate biomarker assays to be implemented in clinical trials? Is working in a cross-functional environment, supporting clinical trials and to shape the future of clinical biomarkers something you are looking for? Then, this opportunity is for you!Your new role

• Presenting strategy-driven biomarker packages at study and program level meetings, as well as communicating these to senior leadership.
• Provide strategic leadership and gain broad, cross-functional alignment of biomarker strategies.
• Developing strategic vision and lead implementation for clinical biomarkers that will broadly enable advances in indication selection, biological activity and patient stratification/selection.

• Working closely with both internal and external stakeholders to ensure effective project execution.
• The biomarker lead, together with subject matter expert, is responsible to determine assay requirements to meet regulatory requirements.
• Represent Lundbeck when interacting with CROs, attending conferences, KOL interactions etc.

Your future teamThe Clinical Biomarkers team is led by the Head of Clinical Biomarkers whom you will report directly to. We are 8 team members with expertise in both fluid and imaging biomarkers and collaborates across our specialties supporting clinical trials as well as with our colleagues in Research. The Clinical Biomarkers Department is part of Experimental Medicine within Global Clinical Development at Lundbeck.The position is based in Valby, Denmark.What you bring to the teamMinimum requirements:

• A PhD +7 years of experience in a similar role in neuroscience or neuroimmunology from pharma or biotech.
• Expertise in defining criteria for assay development to ensure performance and regulatory requirements.
• Presenting strategy-driven biomarker packages at study and program level meetings, as well as communicating these to senior leadership.
• Provide strategic leadership and gain broad, cross-functional alignment of biomarker strategies.
• Developing strategic vision and lead implementation for clinical biomarkers that will broadly enable advances in indication selection, biological activity and patient stratification/selection.
• Collaborative mindset and skilled in interpersonal interactions and stakeholder management.
• Proficient in spoken and written English.

Additional competence:

• Hands on experience in regulatory interactions and filing.
• Strong scientific background (publication track record) in translational sciences.

• Personal track record in a matrix leadership role.

• Strong understanding of clinical drug development strategies under GxP.
• Experience in integration of AI to programs

Our promise to youLundbeck 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 on 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 .Apply nowCan you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you! 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.Applications must be received by July 21st, 2025Learn more about us at , or Instagram (@h_lundbeck).#EveryBrainInTheGameThis job ad is intended for individuals seeking a career opportunity with Lundbeck. 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.

Expected salary

Location

København

Job date

Wed, 25 Jun 2025 22:29:17 GMT

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