Biomarker Lead (Clinical Project Manager) (m/f/d)

Key Responsibilities

• Serve as the scientific, strategic, and tactical biomarker leader at the project level, driving impactful and differentiated biomarker strategies.
• Define and own biomarker strategies at the project, indication, and study levels in collaboration with Clinical Study Leads and Biomarker Study Experts.
• Lead matrixed teams of biomarker subject matter experts and cross-functional representatives to align stakeholders on portfolio-wide biomarker plans.
• Oversee the concept development, endorsement, implementation, and delivery of biomarker strategies.
• Ensure seamless integration of biomarker plans into clinical protocols and operational milestones.
• Interpret and contextualize biomarker data to inform clinical decision-making, including proof of concept/mechanism, dose selection, safety evaluation, and competitive differentiation.
• Represent Biomarker Development functions in Therapeutic Area committees and governance reviews.
• Communicate biomarker findings internally and externally through abstracts, presentations, and peer-reviewed publications.
• Enable rigorous testing of biological and therapeutic hypotheses in early clinical studies, generating clear proof-of-concept or proof-of-mechanism outcomes.
• Advance and qualify biomarkers that support precision medicine approaches and patient stratification strategies.
• Drive innovative biomarker solutions, including tissue-based readouts, near-patient testing, and cost-effective study designs.
• Influence project timelines, resource allocation, regulatory submissions, and broader portfolio decisions.

Requirements:

• MD or PhD required.
• Minimum 5 years of experience in the pharmaceutical or biotechnology industry.
• Demonstrated scientific excellence or clinical expertise in immunological diseases or related therapeutic areas.
• Proven expertise in translational research and biomarker strategy development.
• Strong experience applying biomarkers to clinical decision-making, including pharmacodynamics, efficacy assessment, disease characterization, patient stratification, and precision medicine.
• Experience interpreting and translating omics data (genetics, genomics, proteomics, etc.) into clinically actionable insights in collaboration with research, data science, and clinical development teams.
• Deep understanding of integrating multiple biomarker modalities (genetic, genomic, soluble, cellular, imaging, digital) into clinical development programs.
• Demonstrated success leading global, cross-functional matrix teams with strong influencing and communication skills.
• Strategic thinker with the ability to balance high-level vision and detailed scientific rigor.
• Strong publication record or evidence of scientific dissemination.
• Fluency in written and spoken English; additional European languages are advantageous.