Associate Principal Scientist, Toxicokinetics

Job Description

The Toxicokinetics group within the Translational Modeling group of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) in West Point, PA is seeking a highly motivated Associated Principal Scientist with wide knowledge of pharmacokinetic (PK) and toxicokinetic (TK) principles and modeling techniques. The individual will be responsible for executing all phases/aspects of toxicokinetics support of nonclinical toxicity studies [ie, exploratory and definitive/Good Laboratory Practice (GLP)], serving as a contributing scientist/principal investigator on toxicity studies, and executing PK/TK strategies to support the development of small molecules and biologics.

The successful candidate will collaborate on cross-functional teams to ensure analytical solutions and interpretations are appropriate to address program goals or capability gaps. They will interpret results in the context of the toxicological question at hand and clearly and effectively deliver conclusions to stakeholders. They will thrive in a dynamic work environment. They will demonstrate practical problem-solving skills and the ability to communicate effectively both verbally and in writing.

Key Responsibilities:

• Serve as a contact for all TK-related issues pertinent to the development of assigned drug candidates and closely interact with toxicology study directors, project representatives, bioanalytical scientists, drug metabolism and translational modeling representatives, and other relevant functional areas.

• Serve as a contributing scientist on toxicology studies, and execute all phases/aspects of the toxicokinetics evaluation with minimum supervision. Essential duties include, but are not limited to the following: conduct TK modeling to support dose-selection on toxicity studies, provide TK study design, calculate PK/TK parameters, interpret results, and write reports to a high standard in accordance with external and internal regulations.

  • Ensure compliance with GLP, SOPs, and study protocols.

  • Deliver high quality scientific results according to agreed timeline for several concurrent studies.

  • Effectively communicate study results at internal meetings, as appropriate.

• Mentor junior-level staff as appropriate

• Participate on due diligence projects for toxicokinetic evaluation of nonclinical programs.

• Future potential to represent the department on cross-functional early drug development project teams of drug candidates, responsible for providing departmental strategy, and authoring nonclinical sections of regulatory filings.

• Identify opportunities for process improvements and participate in cross-functional efforts to improve quality and efficiency.

Note:  We are hiring in South San Francisco, CA, Boston, MA or West Point, PA based on candidate preference.

Qualifications:

Education:

• Master's (with 8+ years) or Ph.D. (with 3+ years) in Pharmacokinetics, Toxicology, Pharmacology or related scientific discipline and relevant experience listed below

Required Experience and Skills:

• Strong knowledge of pharmacokinetics/toxicokinetics, pharmacokinetic modeling (NCA analysis, nonparametric superposition, and compartmental PK modeling), and drug metabolism is required with demonstrated hands-on proficiency with Phoenix

• Strong leadership, interpersonal, communication, problem solving, and collaboration skills, with ability to work independently, along with strengths in delivering results for multiple projects in a fast-paced environment

Preferred Experience and Skills:

• Knowledge and experience in PK/PD fundamentals

#EligibleforERP 

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