Associate Principal Scientist, Pharmacokinetics

Merck•Upper Gwynedd Township, PA

2d•$142,400 - $224,100•Hybrid

About The Position

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of the Research & Development Division in West Point, Pennsylvania, is seeking a collaborative scientist for its Drug Metabolism and Pharmacokinetics (DMPK) group. The Associate Principal Scientist contributes to multidisciplinary drug discovery and development by providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug-drug interaction (DDI) risks for novel therapeutics across modalities. The role involves working with cross-functional teams to guide the design and interpretation of in silico, in vitro, and in vivo analyses supporting the discovery of therapeutics with desired DMPK profiles. The scientist assesses DDI risks using static mechanistic and/or physiologically based pharmacokinetic (PBPK) models, advises clinical development teams on DDI strategy, and authors source reports and documents for regulatory filings. The role also evaluates potential program risks and implements strategies to address liabilities and support efficient program progression and decision-making. The position is based primarily in West Point, Pennsylvania, with a hybrid work arrangement. Domestic or international relocation is available, visa sponsorship is offered, and travel requirements are 10%.

Requirements

B.S., Master's degree, or Ph.D. in Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, Biochemistry, or a relevant field.
B.S. or Master's degree with at least 8 years of relevant experience, or Ph.D. with at least 5 years of industry experience in a relevant field focused on discovery and development of therapeutics across modalities.
Experience integrating preclinical DMPK and pharmacology for translational modeling and simulation to support dose selection, PK/PD and safety assessment study design, and preclinical and clinical dose justifications.
Experience assessing factors affecting the pharmacokinetics and pharmacodynamics of novel therapeutics and communicating analyses and recommendations to interdisciplinary teams and management.
Experience authoring documents supporting IB, IND, WMA filings, and responses to regulatory inquiries.
Demonstrated effectiveness as a collaborator on multidisciplinary discovery and development teams.
Strong leadership, interpersonal, communication, problem-solving, and collaboration skills, with the ability to deliver results on firm deadlines.
Ability to work collaboratively in a fast-paced environment and drive scientific development and innovation.
Required skills include bioanalytical techniques, cell-based assays, clinical development, DMPK, drug development, flow cytometry, immunoassays, and liquid chromatography-mass spectrometry (LC-MS).

Nice To Haves

Experience supporting both small-molecule and biologics programs.
Strong publication track record.
Experience building models and performing analyses using Phoenix and PBPK modeling software such as SimCYP.
Experience mentoring or supervising junior staff.

Responsibilities

Contribute to multidisciplinary drug discovery and clinical development efforts across therapeutic modalities.
Guide the design and interpretation of in silico, in vitro, and in vivo analyses to support desired DMPK profiles.
Assess DDI risk using static mechanistic and/or PBPK models.
Guide clinical development teams on DDI strategy.
Author source reports and documents supporting regulatory filings and responses to regulatory inquiries.
Evaluate and predict potential program risks and implement strategies to address liabilities and support efficient program progression and decision-making.
Integrate preclinical DMPK and pharmacology through translational modeling and simulation to support dose selection, PK/PD and safety assessment study design, and dose justifications.
Communicate analyses and recommendations to interdisciplinary teams and management.