Biomarker Lead (Clinical Project Manager) m/f/d, Basel-Stadt The Biomarker Lead (BML) within the Biomarker Development group is responsible for defining and delivering integrated biomarker strategies across an Immunology portfolio spanning early and late clinical development. This role translates preclinical mechanistic insights into indication-relevant, fit-for-purpose clinical biomarker plans and ensures their successful integration into study protocols.
As a core member of cross-functional project teams, the BML leads Biomarker and Diagnostic sub-teams, collaborates closely with Translational Data Science partners, and drives scientific and strategic discussions at both project and governance levels.
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.
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