Director/Senior Director, Clinical Biomarkers

About the role

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.

Responsibilities

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

Requirements

• 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
• Proven ability to interpret biomarker data in the context of other clinical or nonclinical data to generate actionable mechanistic and translational insights
• 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

Qualifications

• Ability to work independently and as part of a team
• Excellent written and verbal communication skills
• Strong organizational and project management skills
• Ability to manage multiple projects simultaneously
• Experience with regulatory requirements and guidelines

Skills

• Biomarker development and validation
• Pharmacodynamics and biomarker interpretation
• Collaboration with cross-functional teams
• Regulatory affairs and submission writing
• Companion diagnostics development

Benefits

• Comprehensive and generous benefits package
• Flexible work arrangements
• Professional development opportunities
• Employee recognition programs

Pay

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.

Schedule

Full-time position