Senior Manager/Associate Director, Clinical Pharmacology

Systimmune•Princeton, NJ

33d•$150,000 - $200,000

About The Position

We are seeking a high-quality Senior Manager/Associate Director of Clinical Pharmacology to lead the development and execution of clinical pharmacology strategies for ADC assets. The ideal candidate will provide expertise in pharmacokinetics, dose optimization, pharmacometrics, and drug interaction assessment, collaborate with cross-functional teams (Clinical, Research, Regulatory, Biometrics, etc.), and manage clinical pharmacology studies, data analysis, and regulatory filings.

Requirements

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.
Minimum 1 - 5 years of experience in clinical pharmacology and pharmacometrics, with hands-on experience in quantitative analysis.

Nice To Haves

Prior experience in the field of ADC development is a plus.

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, 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.