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Merck · 2 hours ago

Principal Scientist, Drug Metabolism and Pharmacokinetics

Lansdale, PA

Full-time

Hybrid

Lead/Staff

$170K/yr - $267K/yr

8+ years exp

Merck is seeking a dynamic and collaborative Principal Scientist for their Drug Metabolism and Pharmacokinetics group in West Point, Pennsylvania. The role involves contributing to multi-disciplinary drug development efforts, assessing DDI risk, and guiding teams on DMPK properties and regulatory filings.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

Responsibilities

Work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities

Guide the design and interpretation of in silico, in vitro, and in vivo analyses to support the discovery of therapeutics with the desired DMPK profile

Assess DDI risk using static mechanistic and/or physiologically based pharmacokinetic (PBPK) models and guide clinical development teams on DDI strategy

Author source reports and documents in support of regulatory filings

Independently evaluate and predict potential program risks, while implementing appropriate strategies to address liabilities to ensure efficient program progression and decision making

Qualification

Drug MetabolismPharmacokineticsPharmacodynamicsDMPKPBPK ModelingADMEBioanalytical Method DevelopmentLiquid Chromatography-Mass Spectrometry (LC-MS)Cross-Functional TeamworkCommunication SkillsProblem SolvingMentoring Staff

Required

PhD or Master's degree in Pharmaceutical Sciences, Pharmacology, Chemistry, Biomedical Engineering, Biochemistry, or relevant life sciences fields

Master's degree with 12+ years relevant experience or PhD with 8 + years of industry experience in a relevant field with a focus on discovery and development of therapeutics of various modalities (including small molecules, antibodies, and drug conjugates)

Experienced in integrating preclinical DMPK and pharmacology to enable translational modeling and simulation to support dose selection, design of PK/PD and safety assessment studies, and dose justifications for preclinical and clinical studies

Experience in assessing the impact of various factors on the pharmacokinetics and pharmacodynamics of novel therapeutics and communicating analyses and recommendations to interdisciplinary teams and management

Experience with authoring documents in support of IB, IND, WMA filings, and responses to regulatory inquiries

Demonstrated track record as an effective collaborator on multi-disciplinary discovery and development teams

Strong leadership, interpersonal, communication, problem solving, and collaboration skills, while delivering results on firm deadlines