Director/Senior Director, Clinical Biomarkers

The Role

We are seeking a Director of Clinical Biomarkers to lead the biomarker strategy and execution across our autoimmune clinical pipeline. This is a scientifically rich cross-functional role sitting at the intersection of translational biology, clinical development, and precision medicine. You will help to define how we measure target and pathway engagement, pharmacodynamic response, and disease modification across our programs - and you will translate those insights into regulatory-grade evidence that supports our clinical and commercial strategies You will partner closely with other functions to integrate biomarker data into clinical programs and advance development, and you will have the opportunity to establish the Biomarker function as a core pillar of our development organization.

What You'll Do

• Define and lead the end-to-end biomarker strategy for one or more autoimmune pipeline programs, encompassing pharmacodynamic, predictive, prognostic, and safety biomarkers
• Develop and execute biomarker plans integrated into clinical protocols, including sample collection strategies, assay selection, and analytical frameworks
• Partner with other functions to translate preclinical mechanistic findings into clinical biomarker hypotheses and early proof-of-mechanism readouts
• Oversee biomarker assay development, validation, and implementation in collaboration with internal and external laboratory partners, ensuring fit-for-purpose analytical performance
• Lead analysis and interpretation of clinical biomarker data, enabling team discussion and decision-making around dose selection, patient enrichment, and go/no-go decisions
• Develop biomarker analysis plans and ensure analytical rigor for biomarker endpoints
• Author biomarker-related sections of clinical protocols, SAPs, clinical study reports, IND/IMPD submissions, and regulatory briefing documents
• Support health authority interactions on biomarker strategy and companion diagnostic (CDx) development pathways where applicable
• Evaluate emerging biomarker technologies and platforms relevant to immunology and inflammation, and recommend adoption where scientifically and operationally justified
• Assist with management of CRO and specialty laboratory partnerships for biomarker sample processing, analysis, and data delivery
• Help build a biomarker function that is scientifically rigorous, operationally excellent, and strategically aligned with program needs

What You Bring

• D. in Immunology, Molecular Biology, Cell Biology, Biochemistry, or a related life science discipline; postdoctoral training preferred
• 10+ years (Director) or 15+ years (Sr. Director) of industry experience in translational or clinical biomarkers, with direct contributions to clinical-stage programs in autoimmune, inflammatory, or oncology disease areas
• Deep expertise in immunology biomarker modalities including flow cytometry, multiplex immunoassay platforms (MSD, Luminex, Olink), gene expression profiling, and tissue-based assays
• Experience overseeing biomarker assay development and validation in accordance with fit-for-purpose and regulatory guidance frameworks
• Strong understanding of translational biology in autoimmune or inflammatory disease; familiarity with relevant disease mechanisms (e.g., cytokine networks, B/T cell biology, complement, innate immune pathways) is essential
• Experience interpreting biomarker data in the context of other clinical or nonclinical data to generate actionable mechanistic and translational insights
• Proven ability to author biomarker content for regulatory submissions and communicate findings to technical and non-technical audiences
• Familiarity with companion diagnostic development pathways and regulatory frameworks (FDA, EMA)
• Track record of effective CRO and vendor management in a resource-constrained, fast-moving biotech environment
• Collaborative scientific leader with the communication skills and strategic perspective to influence program decisions at all levels of the organization

Base compensation for this position ranges from $230,000 - 300,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics' performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.