At a Glance
- Tasks: Lead drug safety strategies for innovative biologics and therapeutics in respiratory and immunology.
- Company: Join Ailux, a pioneering biotech firm shaping the future of drug safety.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Be part of a collaborative team driving innovation in drug safety science.
- Why this job: Make a significant impact on next-gen therapies while advancing your career in a dynamic environment.
- Qualifications: PhD in toxicology or pharmacology with 10-15 years of relevant experience.
The predicted salary is between 121500 - 148500 £ per year.
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
- 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
- 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 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
- Ph D 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
- #J-18808-Ljbffr
Senior Director of Drug Safety in Cambridge employer: AiLux S.r.l.
Ailux is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the vibrant field of drug safety for biologics and peptides. With a strong emphasis on employee growth and development, Ailux offers unique opportunities to lead cutting-edge projects while contributing to meaningful advancements in respiratory and immunology therapies. Located in a dynamic environment, employees benefit from a supportive atmosphere that encourages creativity and professional advancement.
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Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at AiLux S.r.l. that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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