Senior Director of Drug Safety

Senior Director of Drug Safety

Cambridge, UK & Shanghai, China

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, 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, contributing 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 strategyDefine 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 and MAA submissions.
• Contribute to 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, 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.
• Engage 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 a related field
• Approximately 10-15+ years of experience in nonclinical safety within biotech or pharma
• Strong experience designing toxicology strategies for regulatory submission
• Demonstrated experience overseeing GLP and non GLP studies
• Experience supporting regulatory interactions with agencies such as the FDA, EMA or equivalent regulatory authorities

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 is 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 the ability to scale teams in a growing company
• High adaptability in fast paced, evolving environments
• Exceptional communication and regulatory writing skills