Provide nonclinical pharmacology expertise to development and knowledge on biological mechanisms of action of drugs in support of similarity and extrapolation of indications.
Support CMC analytical quality and nonclinical pharmacology from characterization of the originator drug to commercial stage using literature and nonclinical pharmacology data relative to structure-function relationship.
Design and implement CMC pharmacodynamics and nonclinical pharmacology study plans for development projects, highlight risks and issues, and propose mitigation plans.
Provide scientific expertise and take actions from CMC, Nonclinical Pharmacology and Development Teams
Follow international guidelines, necessary quality standards and data management needs to fulfill regulatory requirements.
Ensure sourcing of necessary resources and establish contracts at CRO/CMOs.
Coordinate and guide experimental work done internally or externally.
Oversee assay development and qualification activities, provide support to technology transfer and assay validation for GMP compliant batch release, comparability and stability studies.
Analyze, evaluate and interpret results, establish report templates, review and approve study protocols and CMC and nonclinical pharmacology result reports.
Support cQA assessment and QTPP establishment products.
Assess the overall similarity of the products' biological activity.
Assess product analytical quality data for its relevance at functional level for potential impact on safety and efficacy in the clinic, propose and implement justification packages in support of similarity and extrapolation of indications.
Write and review CMC and nonclinical pharmacology sections for dossiers delivered to regulatory agencies.
Scientific degree (PhD) in Biology, Immunology, Pharmacology or related field
Fluency in English essential, both oral and written
Industry experience with in vitro, ex vivo and in vivo non-clinical pharmacology, auto-immunity and inflammation, and oncology, with a strong knowledge on the different mechanisms of action of biologics and their indications.
Minimum 10 years of relevant experience in biopharma/biotech industry including at mid-management level