This strategic, scientific and operational Project Representative role supports development of new biological entities (NBE: biopharmaceuticals, antibody-drug conjugates). They will be responsible for managing overall immunogenicity and nonclinical drug disposition (i.e. Adsorption, Distribution, Metabolism, Excretion) contributions to NBE projects from hit discovery through life cycle management, thus fulfilling internal and regulatory requirements.
They will be responsible for defining the appropriate project plan, ensuring that studies are conducted on time and with the required quality, and scientific content of regulatory submissions. They will qualitatively integrate the various bioanalytical and immunogenicity data to interpret the drug disposition of the NBE and to perform the immunogenicity risk assessment for assigned projects. They will collaborate with the cross-functional Discovery Project Team for research projects and the Translational team for development projects.
Who you are:
PhD with 5 plus years of experience drug discovery/development of biopharmaceuticals strongly preferred
Bachelor's degree with 8 plus years of experience, master's degree with 3 plus years of experience, or PhD minimum requirement
Excellent knowledge of drug development & discovery processes
Subject matter expert for immunogenicity and/or nonclinical DMPK
Solid understanding of translational sciences, regulatory requirements
General knowledge of disease biology and pharmacology
Strong leadership and influencing skills
Good intercultural understanding
Fluent spoken/written English
Job Requisition ID: 190533
Career Level: D - Professional (4-9 years)
Working time model: full-time
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North America Disclosure
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