Principal Scientist, Drug Metabolism and Pharmacokinetics

Merck•Upper Gwynedd Township, PA

12d•Hybrid

About The Position

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of our Research & Development Division in West Point, Pennsylvania, is seeking a dynamic and collaborative scientist for the Drug Metabolism and Pharmacokinetics (DMPK) group. The Principal Scientist will be a key contributor to multi-disciplinary drug development and discovery efforts providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug interaction (DDI) risk of novel therapeutics. The key responsibilities will be to work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities. The Principal Scientist will 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. They will assess DDI risk using static mechanistic and/or physiologically based pharmacokinetic (PBPK) models and guide clinical development teams on DDI strategy. They will author source reports and documents in support of regulatory filings. They will independently evaluate and predict potential program risks, while implementing appropriate strategies to address liabilities to ensure efficient program progression and decision making. The ideal candidate must be able to work collaboratively in a fast-paced environment, drive scientific development and innovation, and have excellent interpersonal and communication skills. Experience supporting both small molecule and biologics (e.g. antibodies and drug conjugates) programs is desired.

Requirements

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.

Nice To Haves

Strong publication track record
Experience representing the DMPK function in the evaluation of third-party assets.
Experience building models and performing analyses using Phoenix and PBPK modeling software (e.g., SimCYP).
Experience mentoring or supervising junior staff.

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.