Director/Senior Director, Toxicology

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 or Senior Director of Toxicology to lead nonclinical safety strategy across our autoimmune pipeline. This is a foundational role for our growing organization — you will be the internal expert on all matters related nonclinical safety, partnering closely with other functions to advance programs from candidate nomination through IND and into the clinic. You will manage CRO relationships, interface directly with health authorities, and play a key role in shaping the safety profile of our pipeline assets. This role offers significant visibility and the opportunity to build the toxicology function from the ground up.

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  Own and lead nonclinical safety strategy for one or more pipeline programs across small molecules and/or biologics targeting autoimmune and inflammatory diseases

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  Design, oversee, and interpret GLP and non-GLP toxicology studies including single- and repeat-dose tox, genotoxicity, reproductive and developmental toxicology, carcinogenicity, and safety pharmacology

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  Select, contract, and manage CRO partners; serve as scientific point of contact to ensure study quality, timelines, and regulatory compliance

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  Author and review nonclinical sections of IND/IMPD submissions, investigator brochures, toxicology summaries, and integrated summary of safety documents

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  Interpret nonclinical findings in the context of human relevance, and effectively communicate risk assessments to clinical teams, senior leadership, and health authorities

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  Represent toxicology in cross-functional program teams, contributing to candidate selection, TPP development, and go/no-go decisions

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  Support health authority interactions including pre-IND meetings and respond to agency questions related to nonclinical safety

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  Evaluate emerging nonclinical findings and advise on mitigation strategies and clinical monitoring implications

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  Stay current with evolving regulatory guidance (FDA, EMA, ICH) relevant to nonclinical safety in immunology and inflammation

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  Help build a best-in-class nonclinical safety function as the company scales

• Ph.D. in Toxicology, Pharmacology, Pathology, or a related discipline; board certification (DABT) strongly preferred

• 10 + years of industry experience in nonclinical safety, with a track record of advancing programs through IND filing and into clinical development

• Deep expertise in regulatory toxicology and ICH guidelines (S1–S9) as they apply to small molecule and/or biologic drug development

• Hands-on experience designing and managing GLP toxicology studies and CRO oversight

• Experience in immunology, inflammation, or autoimmune disease therapeutic areas strongly preferred; familiarity with immune-related adverse events and immunotoxicology is a plus

• Proven ability to author and defend nonclinical sections of regulatory submissions, including INDs and briefing documents

• Strong scientific judgment — able to weigh complex, sometimes ambiguous nonclinical data and provide clear, actionable risk assessments

• Effective cross-functional collaborator with the communication skills to engage clinical, regulatory, and executive stakeholders

• Comfortable operating in a lean biotech environment where speed, adaptability, and scientific rigor must coexist