Overview
As a Research Leader in Toxicology, you will own safety assessment strategy for drug discovery and development projects from inception through regulatory submission. You will work with drug design platforms to optimize assets using an AI-first approach and guide the development of AI-based toxicology models. You’ll design screening cascades, elucidate liabilities, and shape regulatory safety packages. You join an interdisciplinary team driving AI-enabled, safer drug discovery with meaningful impact on patients.
Responsibilities
- Tailor and implement project-specific safety assessment strategies for small molecules and biologics with an AI-first mindset
- Design screening cascades and mechanistic experiments to identify and mitigate safety risks
- Provide SAR insights to reduce toxicology liabilities and optimize chemical/biological matter
- Define regulatory safety assessment packages to support regulatory acceptance
- Communicate integrated risk assessments and recommendations to internal stakeholders
- Author and defend toxicology sections of regulatory documents
- Maintain and develop CRO relationships to ensure high-quality data generation and leverage external expertise
- Oversee data generation campaigns to support AI-based toxicology models
- Empower team members, share expertise, and promote inclusive professional development
Key requirements
- PhD in Toxicology, Pharmacology, Biology, or related technical field, or equivalent industrial experience
- 8+ years of senior toxicology experience in biotech or pharma
- Proven track record delivering non-clinical safety strategies across therapy areas
- Experience designing, implementing and filing IND packages for small molecules and biologics
- Deep understanding of global regulatory guidelines on safety assessment
- Experience partnering with Discovery and Clinical teams
- Excellent communication, interpersonal and influencing skills in cross-functional settings
- Creative problem solving with growth mindset, adaptability, and willingness to learn new concepts
- strong communication skills
- cross-functional collaboration
- growth mindset
- AI/ML techniques in drug discovery
- toxicology predictive models
- regulatory safety assessment
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