Associate Principal Scientist, Pharmacokinetics
About The Position
The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function in the Research & Development Division 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 integrating understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug–drug interaction (DDI) risk for novel therapeutics across modalities. The role involves guiding the design and interpretation of in silico, in vitro, and in vivo analyses to support therapeutics with desired DMPK profiles. It also includes assessing DDI risk with static mechanistic and/or physiologically based pharmacokinetic (PBPK) models, advising clinical development teams on DDI strategy, and authoring source reports and regulatory documents. The scientist evaluates potential program risks and implements strategies to address liabilities, supporting efficient program progression and decision-making. The ideal candidate works effectively in a fast-paced, collaborative environment, drives scientific development and innovation, and has strong interpersonal and communication skills. Experience supporting both small-molecule and biologics programs is desired.
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 8 or more years of relevant experience, or a Ph.D. with 5 or more years of industry experience in a relevant field focused on discovery and development of therapeutics across modalities.
- Experience integrating preclinical DMPK and pharmacology to enable translational modeling and simulation for dose selection, PK/PD and safety assessment study design, and preclinical and clinical dose justifications.
- Experience assessing factors affecting pharmacokinetics and pharmacodynamics of novel therapeutics and communicating analyses and recommendations to interdisciplinary teams and management.
- Experience authoring documents supporting IB, IND, and WMA filings and responding 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.
- 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 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 discovery of therapeutics with desired DMPK profiles.
- Assess DDI risk using static mechanistic and/or PBPK models and guide clinical development teams on DDI strategy.
- Author source reports and documents supporting regulatory filings.
- Evaluate and predict potential program risks and implement strategies to address liabilities and support efficient progression and decision-making.
- Integrate preclinical DMPK and pharmacology to support translational modeling and simulation, dose selection, PK/PD and safety assessment study design, and dose justifications.
- Assess factors affecting pharmacokinetics and pharmacodynamics of novel therapeutics and communicate analyses and recommendations to interdisciplinary teams and management.
Benefits
- Medical, dental, vision, healthcare, and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
