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Fresenius Kabi Deutschland GmbH

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Senior Manager / Senior Scientist Clinical Pharmacology & Immunology (m/f/d)
Eysins (Schweiz)
Aktualität: 28.01.2022

Anzeigeninhalt:

28.01.2022, Fresenius Kabi
Eysins (Schweiz)
Senior Manager / Senior Scientist Clinical Pharmacology & Immunology (m/f/d)
Identify and oversee bioanalytical laboratories for PK / PD and immunogenicity assay development and validation and sample analysis Request, review and manage contracts with bioanalytical laboratories Review and comment method development, validation and sample analysis plans and reports in terms of science and regulatory compliance On bioanalytical and clinical pharmacology and immunology topics, contribute to regulatory submissions and briefing books Represent the Clinical Pharmacology & Immunology function in Development Teams Collaborate with Clinical Development and other relevant stakeholders to define pharmacology and immunology assessments required for the clinical development of a biosimilar project Liaise with external consultants (e. g. pharmacologists) to gather required information and expertise Work with Project Management to align timelines and budget with the overall development plan Collaborate with Clinical Operations to ensure adequate PK / PD and immunogenicity sample collection, management, handling and shipmentoks
Scientific degree (MS or PhD) in Biochemistry, Chemistry, Immunology or related field Good knowledge of GLP and Bioanalytical Guidance documents Experience with immunoassays Demonstrated success operating in a team environment Fluency in English, both oral and written Minimum 7 years of relevant experience in R&D organization of Biopharma / Biotech Company Experience and successful track record with CRO Management for bioanalytics (PK and immunogenicity) Experience with biosimlars is an advantage

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