Director/Senior Director, Clinical Biomarkers

Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco, focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need. Our pipeline is anchored by T‑cell engager programs, led by a potential first‑in‑class clinical asset and complemented by an exciting preclinical portfolio in autoimmune disease.

Our lead asset is being developed for severe immune‑mediated diseases, while additional preclinical programs expand the long‑term potential of our R&D pipeline. At Lakefront, we focus on advancing programs with strong biological rationale, clear clinical proof of concept and large commercial opportunities.

Are you ready to transform lives and be part of a journey like no other? We are building a company where science, execution, and accountability matter. Rather than layers of hierarchy, we operate with small, empowered teams that work hands‑on across development stages to move programs forward efficiently and thoughtfully.

We are looking for people who want to contribute directly, who are motivated by solving real problems, collaborating across disciplines, and taking ownership from idea to impact. At Lakefront, every role plays a part in shaping the future of medicines that have the potential to make a meaningful difference for patients.

If you are driven to improve the lives of patients, energized by execution, and excited to help build a growing company with a strong balance sheet, we look forward to meeting you.

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.

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  Define and lead the end-to-end biomarker strategy for one or more autoimmune pipeline programs, encompassing pharmacodynamic, predictive, prognostic, and safety biomarkers

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  Develop and execute biomarker plans integrated into clinical protocols, including sample collection strategies, assay selection, and analytical frameworks

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  Partner with other functions to translate preclinical mechanistic findings into clinical biomarker hypotheses and early proof-of-mechanism readouts

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  Oversee biomarker assay development, validation, and implementation in collaboration with internal and external laboratory partners, ensuring fit-for-purpose analytical performance

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  Lead analysis and interpretation of clinical biomarker data, enabling team discussion and decision-making around dose selection, patient enrichment, and go/no-go decisions

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  Develop biomarker analysis plans and ensure analytical rigor for biomarker endpoints

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  Author biomarker-related sections of clinical protocols, SAPs, clinical study reports, IND/IMPD submissions, and regulatory briefing documents

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  Support health authority interactions on biomarker strategy and companion diagnostic (CDx) development pathways where applicable

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  Evaluate emerging biomarker technologies and platforms relevant to immunology and inflammation, and recommend adoption where scientifically and operationally justified

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  Assist with management of CRO and specialty laboratory partnerships for biomarker sample processing, analysis, and data delivery

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  Help build a biomarker function that is scientifically rigorous, operationally excellent, and strategically aligned with program needs

• Ph.D. in Immunology, Molecular Biology, Cell Biology, Biochemistry, or a related life science discipline; postdoctoral training preferred

• 10+ years 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