Nonclinical safety and DMPK- Senior Scientist

1 mese fa


Roma, Italia Antal International Network A tempo pieno

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 stages of drug development.
This position is open to hybrid working arrangements; however, candidates with remote work arrangements will be considered.
Responsibility
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
Calculate and analyze PK properties and implications of small molecules and biologics
Author nonclinical sections of 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 of 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 results
Per favore, mandate il vostro CV con una lettera di motivazione al ruolo a: lcarbone@antal.com
Ref : Nonclinical safety and DMPK- Senior Scientist
Le candidature ritenute in linea saranno contattate entro 30 giorni dalla ricezione della candidatura.
Grazie fin d’ora a tutti coloro che vorranno trasmetterci il loro CV e, in caso di mancata convocazione, considereremo il profilo professionale per eventuali esigenze future.

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