Senior Director of Drug Safety

The Company

Ailux is an innovative biotechnology company focused on discovering and developing next-generation biologic and peptide therapeutics for chronic respiratory and immunological diseases with high unmet medical need. The company integrates advanced computational approaches with rigorous experimental and translational science across the drug discovery continuum, enabling faster and more informed decision-making from target identification through clinical candidate selection.

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As an AI-native biotech and wholly owned subsidiary of XtalPi, Ailux combines proprietary computational models with state-of-the-art wet lab capabilities to design differentiated therapeutics against challenging biological targets. The company has established strategic partnerships with leading pharmaceutical organisations, providing external validation of its scientific platform and discovery capabilities. Looking ahead, Ailux’s vision is to build a fully integrated, end-to-end drug discovery and development organisation capable of delivering the next generation of medicines for patients with chronic respiratory and immunological diseases. By combining advanced AI capabilities with deep biological, translational and clinical insight, the company aims to accelerate the development of differentiated therapeutics with meaningful impact for patients worldwide.

Backed by an experienced leadership team, leading scientific advisors and a highly multidisciplinary organisation, Ailux is approaching a key inflection point as its first wave of therapeutic programmes advances toward clinical development. This is an opportunity to help shape the scientific foundations, pipeline and culture of a rapidly growing biotechnology company operating at the intersection of AI, translational science and next-generation therapeutics.

The Role

We are seeking an experienced and strategic Head of Drug Safety to establish and lead Ailux’s translational safety sciences capability across its respiratory and immunology pipeline. Reporting to the VP, Head of In Vivo Bioscience, the role will shape nonclinical and translational safety strategies supporting the progression of novel biologics, multi-specific antibodies and peptide therapeutics from discovery through early clinical development.

Working at the interface of computational design, translational biology and preclinical development, you will integrate mechanistic toxicology, pharmacology, DMPK and emerging clinical insights to enable informed, data-driven programme decisions and successful human translation.

The role offers the opportunity to shape translational safety strategy across a next-generation respiratory and immunology pipeline spanning biologics, multi-specifics and peptide therapeutics.

Key responsibilities

Strategic leadership & portfolio impact

• Lead the nonclinical safety strategy across Ailux’s pipeline
• Shape candidate selection and go/no-go decisions through integrated mechanistic and translational safety assessment, balancing target biology, therapeutic index, exposure margins and clinical risk.
• Partner closely with DMPK, bioscience, translational and clinical teams to integrate PK/PD, exposure-response and safety data into human dose prediction and first-in-human strategy
• Partner with Platform Science teams to evaluate and optimise emerging technologies.

Scientific Oversight (Toxicology & Translational Safety)

• Design and oversee nonclinical safety strategies supporting discovery through IND-enabling development for biologics, multi-specific antibodies and peptide therapeutics
• Provide strategic oversight across general toxicology, safety pharmacology, DART (developmental and reproductive toxicology), genotoxicity and investigative toxicology activities
• Integrate toxicology, pharmacology, DMPK, biomarker and translational datasets to support mechanistic interpretation and human risk assessment
• Interpret animal safety findings within the context of target biology, pharmacology and human relevance, including assessment of species translatability and exaggerated pharmacology risks
• Develop translational safety strategies incorporating exposure margins, toxicokinetics, biomarker approaches and emerging clinical data to support dose selection and clinical monitoring plans
• Contribute to optimisation of therapeutic index through integrated interpretation of efficacy, exposure and safety datasets
• Support first-in-human and early clinical programmes through integrated interpretation of nonclinical and emerging human safety data. xwwtmva Contribute to clinical risk mitigation strategies, safety monitoring approaches and dose escalation recommendations

Execution & Programme Leadership

• Oversee the design, execution and interpretation of GLP and non-GLP in vitro and in vivo safety studies across multiple species
• Apply quantitative and translational safety approaches, including toxicokinetic modelling and exposure-margin assessment, to support programme decision-making and clinical development strategy
• Define safety strategies for complex therapeutic modalities including multi-specific antibodies, engineered biologics, immune modulators, peptides and targeted delivery approaches
• Ensure delivery of high-quality, decision-enabling safety data packages supporting portfolio progression
• Act as Toxicology Lead on selected programmes, maintaining hands-on scientific contribution and strategic oversight

Regulatory leadership

• Lead nonclinical contributions to:
• IND / CTA / BLA / MAA submissions
• Regulatory briefing documents and responses
• Serve as a key scientific representative in regulatory interactions
• Ensure alignment between nonclinical findings, clinical strategy, and regulatory expectations

Data interpretation & communication

• Translate complex datasets into clear safety narratives and strategic recommendations
• Present nonclinical findings to:
• Internal leadership and governance boards
• External partners and regulators
• Ensure consistency and clarity across all safety communications

External scientific presence

• Maintain visibility in the scientific community through:
• Publications and conference presentations
• Engagement with external experts and advisors
• Help position Ailux as a leader in next-generation safety science

Qualifications & experience

• PhD (or equivalent) in toxicology, pharmacology, or related field
• ~10–15+ years in nonclinical safety within biotech/pharma
• Strong experience in:
• Designing toxicology strategies for regulatory submission
• GLP/non-GLP study oversight
• Regulatory interactions (FDA, EMA, etc.)

Highly valuable

• Experience supporting complex therapeutic modalities including multi-specific antibodies, engineered biologics, immune modulators, peptides and targeted delivery approaches
• Understanding of modality-specific safety considerations including exaggerated pharmacology, cytokine-mediated liabilities, immunogenicity, and tissue-specific toxicities
• Background in respiratory and Immunology indications preferable.
• Exposure to platform technologies or early-stage biotech environments

Core competencies

• Deep expertise in toxicology and nonclinical safety sciences
• Strategic thinking across the full drug development lifecycle
• Strong leadership with ability to scale teams in a growing company
• High adaptability in fast-paced, evolving environments
• Exceptional communication and regulatory writing skills