As a Senior Scientist Nonclinical safety and Drug Metabolism and Pharmacokinetics, you will provide support to ongoing and planned nonclinical programs at early and late stage of drug development. This position is open to hybrid working arrangements, however candidates with remote work arrangement will be considered.
Responsability
Lead non-clinical ADME and PK drug development plans Oversee, design, and report on nonclinical DMPK and drug safety studies in accordance with international regulatory requirements Manage contract laboratories, outsourced activities and ensure delivery of high quality nonclinical reports that meet regulatory requirements Calculates and analyze PK properties and implications of small molecules and biologics Author nonclinical sections INDs, IBs, annual reports and NDAs Contribute to the nonclinical data (such as allometric scaling, nonclinical PK/PD) to support human dose prediction Contribute to in-licensing activities evaluating external opportunities and participating in due diligence Experience and Qualification
PhD, in life sciences, pharmacokinetics, pharmacology or a related discipline with 5-7 years' experience in nonclinical DMPK within Translational R&D A strong background in pharmacology, toxicology, DMPK, drug discovery and development, and global regulatory requirements is required, with a focus in Oncology Knowledge of GLP and ICH from first-in-human to market authorization Fluency in English (both oral and written) Strong team player, looking to drive further projects and innovation Strong work ethic and commitment to timely delivery of the results Per favore, mandate il vostro CV con una lettera di motivazione al ruolo a:
Ref : Nonclinical safety and DMPK- Senior Scientist
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