Principal Scientist Nonclinical Pharmacology Biosimilars
A global healthcare company that specializes in lifesaving medicines is looking for an experienced Senior Manager- Principal Scientist of Nonclinical Pharmacology Biosimilars. The Swiss based role is dedicated to creating products and services that are used to help care for critically and chronically ill patients.
- Provide nonclinical pharmacology expertise to biosimilar 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 biosimilars development projects, highlight risks and issues, and propose mitigation plans.
- 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.
Skills and Requirements
- Scientific degree (PhD) in Biology, Immunology, Pharmacology or related field
- Fluency in English essential, both oral and written
- Industry and academic experience with in vitro, ex vivo and in vivo non-clinical pharmacology, auto-immunity and inflammation, and oncology.
- Minimum 10 years of relevant experience in R&D of biopharma/biotech industry, including at mid-management level
- A successful track record with CRO/CMO management for CMC and nonclinical pharmacology, ideally for biosimilars.
- Good background or understanding of CMC analytical development, process development and manufacturing of biologics in general.
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