Job Details

Overview

We are seeking an Associate Director of Quantitative Modeling to lead and execute advanced modeling and simulation strategies supporting drug development across early and late-stage programs. This individual will play a critical role in informing decision-making through quantitative insights spanning pharmacokinetics, pharmacodynamics, disease progression, and trial design.

This is a high-impact, cross-functional role partnering closely with Clinical Pharmacology, Biostatistics, Clinical Development, and Regulatory teams to optimize development strategy and accelerate asset progression.

Key Responsibilities

• Lead the design, development, and application of PK/PD, PopPK, PBPK, and disease progression models to support clinical development programs

• Drive model-informed drug development (MIDD) strategies across multiple assets and indications

• Develop exposure-response analyses to inform dose selection, trial design, and labeling strategy

• Apply quantitative frameworks to support Phase 1 through Phase 3 decision-making

• Serve as a key contributor to clinical and regulatory strategy through quantitative insights

• Influence study design, endpoint selection, and go/no-go decisions using modeling outputs

• Support regulatory submissions including INDs, NDAs, and briefing documents with modeling components

• Interface with FDA and other health authorities on MIDD approaches when applicable

• Partner with Clinical Pharmacology, Biostatistics, Data Science, and Clinical Operations teams to integrate modeling into development plans

• Translate complex quantitative findings into clear, actionable insights for non-technical stakeholders

• Oversee external modeling vendors and ensure adherence to timelines, quality standards, and regulatory expectations

• Maintain documentation and ensure reproducibility and compliance with industry standards (e.g., NONMEM, Monolix, R-based workflows)

Qualifications

• PhD in Pharmacometrics, Biomedical Engineering, Applied Mathematics, Statistics, or related quantitative field

• 6–8+ years of relevant experience in biotech, pharma, or CRO environments

• Demonstrated experience supporting clinical development programs with modeling and simulation

• Strong hands-on experience with PK/PD modeling, PopPK, and exposure-response analysis

• Proficiency with tools such as NONMEM, Monolix, Phoenix NLME, R, MATLAB, or similar platforms

• Experience with PBPK modeling (e.g., Simcyp, GastroPlus) is a plus

• Familiarity with regulatory expectations for MIDD submissions

• Ability to operate as a strategic and hands-on contributor in a fast-paced biotech environment

• Strong cross-functional collaboration skills and ability to influence without authority

• Excellent communication skills with the ability to distill complex quantitative concepts into business-relevant insights

Preferred Experience

• Prior experience in small to mid-sized biotech environments

• Experience supporting regulatory interactions involving modeling and simulation

• Background in oncology