Job Description
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 arrangements will be considered.
Responsibilities
- 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 and outsourced activities while ensuring 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 by evaluating external opportunities and participating in due diligence.
Experience and Qualification
Education: PhD in life sciences, pharmacokinetics, pharmacology or a related discipline with 5-7 years’ experience in nonclinical DMPK within Translational R&D.
Skills: A strong background in pharmacology, toxicology, DMPK, drug discovery and development, and global regulatory requirements is required, with a focus in Oncology.
Knowledge: Knowledge of GLP and ICH from first-in-human to market authorization.
Language: Fluency in English (both oral and written).
Attributes: 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: 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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