Associate Director Of Quantitative Modeling, Hayward

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