Associate Director, Clinical Pharmacology: Oncology ADCs

SystImmune; Princeton (NJ); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

SystImmune seeks a Senior Manager/Associate Director of Clinical Pharmacology to lead PK/PD and pharmacometrics strategies for ADC assets. You will collaborate with Clinical, Research, Regulatory, Biometrics, and others, managing pharmacology studies, data analyses, and regulatory filings.

The role requires expertise in dose optimization, DDI assessment, and quantitative analyses across all development phases, including regulatory interactions.

Qualifications

• Experience with first-in-human and proof-of-concept studies.
• Understanding of drug development including MIDD and the R&D process.
• ADC development experience is a plus.

Responsibilities

• Lead high-complexity oncology clinical pharmacology studies.
• Guide dose and schedule optimization; address DDI with cross-functional colleagues.
• Perform quantitative pharmacology analyses and interpret study results.
• Conduct pharmacometric analyses to support drug development.
• Lead preparation and review of clinical pharmacology sections for protocols, reports and regulatory filings.

Skills

PK/PD modeling

Exposure-Response

Quantitative pharmacology

Regulatory submissions

MIDD

Education

MS/PhD in pharmacology

Tools

NONMEM

R

Simcyp

WinNonlin

Job description

SystImmune seeks a Senior Manager/Associate Director of Clinical Pharmacology to lead PK/PD and pharmacometrics strategies for ADC assets. You will collaborate with Clinical, Research, Regulatory, Biometrics, and others, managing pharmacology studies, data analyses, and regulatory filings.

The role requires expertise in dose optimization, DDI assessment, and quantitative analyses across all development phases, including regulatory interactions.