Scientist II, DMPK

The Opportunity:

The DMPK Scientist will be a key member of the Drug Metabolism and Pharmacokinetics (DMPK) team within the Nonclinical Development and Clinical Pharmacology (NDCP) department.

Specifically, you will:

• Design and execute in vitro and in vivo metabolite identification studies using liver microsomes, hepatocytes, recombinant enzymes, and biological samples (blood, plasma, tissue, urine, bile, etc.), and perform metabolite profiling and structural elucidation.

• Characterize major, unique, or disproportionate metabolites to support candidate selection, MIST (Metabolites in Safety Testing) analysis, and metabolite regulatory strategy.

• Design and perform mechanistic studies to understand metabolic pathways and enzyme kinetics; work with pharmaceutical product teams to characterize drug degradation products and impurities.

• Author and review DMPK sections of regulatory submissions and respond to questions from regulatory agencies.

• Build and maintain strong collaborative partnerships across functional areas, e.g., Discovery research, Clinical Pharmacology, Medicinal Chemistry, Pharmaceutical Development, Toxicology, and Translational Research.

Required Skills, Experience and Education:

• A highly motivated individual with a PhD in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field, with 3+ years of experience after graduation.

• Demonstrated hands-on experience in metabolite profiling using high resolution mass spectrometry.

• Solid understanding of drug metabolism, pharmacokinetics, and ADME principles.

• Demonstrated hands-on experience in using PK software (e.g. WinNonlin).

• Excellent verbal and written communication, problem-solving and critical thinking skills.

• Ability to independently design experiments, analyze data, and communicate results.

Preferred Skills:

• Prior experience with oncology drug discovery is preferred.

• Previous experience with PBPK modeling and DDI risk assessment is preferred.

• Effective communication and documentation skills.

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