Associate Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (QP2‑IO)
Core
Lead quantitative pharmacology and pharmacometrics strategies for oncology drug development from post-PCC to registration, optimizing model-based analyses and regulatory submissions.
Role type
Associate Director, Quantitative Pharmacology and Pharmacometrics (Immuno-Oncology)
Builds
Novel chemical entities in oncology
Domain
Biopharmaceuticals, Immuno-Oncology, Clinical Development
Deliverable
production ML models | dashboards & analysis
Required skills
Pharmacometrics, Experimental design, Mathematical problem solving, Critical data analysis, Statistics, R, NONMEM
Preferred skills
Phoenix WinNonlin, Population Pharmacokinetics, Tumor size modeling, Survival endpoint modeling, Regulatory writing
Technologies
NONMEM, R, Phoenix WinNonlin
Responsibilities
Serve as expert representative for QP2-IO on Oncology clinical development teams; Frame critical questions for optimizing model-based analyses; Develop and execute model-based analyses including translational PK/PD, population PK, exposure-response, and QSP modeling; Strategize and execute modeling of tumor size and survival endpoints; Author regulatory documents (INDs, CSRs, CTDs) and represent QP2-IO at regulatory meetings.
Seniority
Senior, hands-on IC with strategic oversight
