Distinguished Scientist, Pharmacokinetics

MSD; West Point (PA); On-site; USD 180,000 - 260,000; Full time

Job summary

MSD Malaysia is seeking a Distinguished Scientist to serve as a Drug Metabolism and Pharmacokinetics (DMPK) submission expert. This leader will support our development pipeline to ensure robust filings from FIH to marketing and through life-cycle management.

The role influences regulatory filings, labeling discussions and approvals as part of the DMPK Leadership team. The Distinguished Scientist will bring forward drug disposition properties within regulatory guidelines and contribute to program

Job description

Job Description

The department of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) is seeking a Distinguished Scientist to serve as Drug Metabolism and Pharmacokinetics (DMPK) submission expert. This leader will have broad responsibilities in support of our robust development pipeline to ensure consistent quality filings from FIH to marketing applications and through life-cycle management. The Distinguished Scientist will contribute to the execution of PDMB portfolio support strategy and DMPK priorities across therapeutic areas and modalities. The successful candidate will ensure that submission packages as they pertain to nonclinical Pharmacokinetics (PK) are robust and aligned with program objectives. They will bring forward drug disposition properties in the context of benefit/risk and drug interaction potential in target populations within the parameters of regulatory guidelines. The Distinguished Scientist will be positioned to influence portfolio decisions, contribute to regulatory filings, labeling discussions and approvals. As a member of the DMPK Leadership team, the Distinguished