Head Of Translational Medicine
Current• In-depth understanding of tumor oncology and rare disease, knowledge ofevolving therapeutic landscape, regulatory affairs, competitive scenarios; Breadth oftherapeutic modalities expertise and exposure to multiple therapeutic modalities,including small molecules and biologics drug • Evaluate, triage and cross-validate preclinical targets which are discovered viagenomic platform with mechanistic biology, chemistry, and disease models information.• Lead translational pharmacology activity of leveraging quantitative and model-basedapproaches (PK/PD, TK, biomarker) to support non-clinical development programs.Direct toxicology strategies to predict, assess and mitigate target/modality-related safety risks in small molecules and biologics drug discovery programs.• Manage CRO/CDMOs on technologies, set expectations and timelines, develop projectplans, apply fit-for-purpose platforms and technical approaches. Ensure that projectsare developed and validated according to regulatory guidance. Interact with regulatory agencies on preclinical matters. Write, review, edit preclinical reports for IND submissions including the section of pharmacology, biodistribution, immunogenicity and toxicology studies.