Sr. Manager/Associate Director, Clinical Pharmacology

United States·Princetonsenior

OtherAssociate

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Quick Summary

Key Responsibilities

Play a pivotal role in planning and conducting cutting-edge oncology clinical pharmacology studies that are of higher complexity both in scope and volume. Guide dose and schedule determination,

Requirements Summary

Experience with a range of clinical studies including first-in-human, proof-of-concept and registrational studies Understanding of drug development,

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OtherAssociate

What We Offer

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Responsibilities

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→Play a pivotal role in planning and conducting cutting-edge oncology clinical pharmacology studies that are of higher complexity both in scope and volume.
→Guide dose and schedule determination, dose optimization, and drug-drug interaction issues, collaborating closely with cross functional colleagues.
→Perform quantitative pharmacology analyses and contributes to the interpretation of study results through all phases of clinical development.
→Perform pharmacometric analyses to support drug development and address scientific questions.
→Take a lead role in preparing and meticulously reviewing clinical pharmacology sections of study protocols, reports, investigators' brochures and regulatory filings (IND’s, BLA’s, etc.), and responds to regulatory inquiries related to clinical pharmacology.

Requirements

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Experience with a range of clinical studies including first-in-human, proof-of-concept and registrational studies
Understanding of drug development, including model informed drug development (MIDD) and the overall pharmaceutical R&D process.
Advanced knowledge and understanding of pharmacokinetics (PK), pharmacodynamics (PD), PK/PD, Exposure-Response (ER), and Quantitative systems pharmacology.
Demonstration of strong quantitative skills, conceptual, technical and hands on development expertise with modelling and simulation activities (NCA, population modelling, exposure-response analyses etc).
Familiar with analysis software (e.g., NONMEM, R, Simcyp, WinNonlin) along with PK modeling and computer skills in scientific graphing.

MS, PharmD, or PhD in biological or pharmaceutical sciences, with a focus on pharmacology and pharmacometrics.
Understanding of clinical pharmacology study design, data analysis, and regulatory requirements.
Minimum1 - 5 years of experience in clinical pharmacology and pharmacometrics, with hands-on experience in quantitative analysis.
Prior experience in the field of ADC development is a plus.