What awaits you:
- Develop and execute integrated research strategies (discovery, ADME, toxicology, pharmacology, and biomarkers) supporting programs from discovery, PCC, and IND‑enabling through early clinical development
- Serve as the research and nonclinical development lead on cross-functional program teams (including overseas partners), providing scientific input to development strategy, risk assessment, and decision-making
- Assess nonclinical data packages, identify gaps and risks, and propose mitigation strategies aligned with ICH guidelines, GLP regulations, and evolving global regulatory expectations
- Support the design and oversight of nonclinical toxicology studies at external CROs, providing scientific oversight of protocols, execution, data interpretation, and final reports, and managing CRO relationships, timelines, and budgets
- Provide scientific leadership for mechanism-based safety assessment, integrating safety data to inform translational and clinical plans
- Author, review, and/or substantially contribute to nonclinical sections of regulatory documents, and partner closely with Regulatory Affairs to support health‑authority interactions
- Lead translational medicine development strategies across preclinical and early clinical ADC programs
- Synthesize complex nonclinical data into clear, coherent narratives to support internal decision-making, regulatory filings, and external communications with partners and due‑diligence stakeholders
- Collaborate closely with Clinical Development, Regulatory Affairs, CMC, and Clinical Operations to ensure alignment of nonclinical plans with the overall development strategy
- Operate effectively in a dynamic environment, demonstrating flexibility, agility, and the ability to rapidly learn, adapt, and contribute to the evolution of nonclinical standards and ways of working across the organization
