Associate Director, Pharmacometrics, Clinical Pharmacology
Travere Therapeutics
10 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Position Summary:
Design, lead, and implement Modeling & Simulation strategies across Travere clinical programs; perform or supervise pharmacometrics strategy execution with a focus on model-informed drug development (MIDD).
Responsibilities:
- Develop and execute modeling and simulation strategies from early through late-stage clinical development; serve as SME in cross-functional development program teams
- Provide strategic, timely modeling input at key development decision points
- Set pharmacometric issue strategy for regulatory submissions influencing drug development decisions
- Lead/drive PMX contributions to plan and execute robust quantitative development programs focused on MIDD
- Interpret PK/PD data using state-of-the-art modeling/simulation; ensure appropriate PK-PD analysis (population PK, PK-PD modeling/simulation, exposure-response)
- Guide empirical modeling/QSP to understand relationships between PK, biomarkers, and disease outcomes
Education/Experience Requirements:
- PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent) required
- 4+ years relevant industry experience, including NLME methods for dose-exposure-response, population PK/PD modeling, disease progression modeling, and clinical trial simulation
- Clinical pharmacology, statistics, and therapeutic knowledge in one or more disease areas
- Experience incorporating MIDD across all development phases; ability to address dose/regimen justification and study design questions
- Hands-on experience with NONMEM and R strongly preferred
Additional Requirements/Skills:
- Strong organization, multitasking, prioritization, and ability to manage shifting responsibilities and competing timelines
- Strong interpersonal and verbal/written communication skills
- Self-motivated; able to independently manage responsibilities
- Onsite/face-to-face work essential in San Diego; not 100% remote; ability to travel
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Design, lead, and implement Modeling & Simulation strategies across Travere clinical programs; perform or supervise pharmacometrics strategy execution with a focus on model-informed drug development (MIDD).
Responsibilities:
- Develop and execute modeling and simulation strategies from early through late-stage clinical development; serve as SME in cross-functional development program teams
- Provide strategic, timely modeling input at key development decision points
- Set pharmacometric issue strategy for regulatory submissions influencing drug development decisions
- Lead/drive PMX contributions to plan and execute robust quantitative development programs focused on MIDD
- Interpret PK/PD data using state-of-the-art modeling/simulation; ensure appropriate PK-PD analysis (population PK, PK-PD modeling/simulation, exposure-response)
- Guide empirical modeling/QSP to understand relationships between PK, biomarkers, and disease outcomes
Education/Experience Requirements:
- PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent) required
- 4+ years relevant industry experience, including NLME methods for dose-exposure-response, population PK/PD modeling, disease progression modeling, and clinical trial simulation
- Clinical pharmacology, statistics, and therapeutic knowledge in one or more disease areas
- Experience incorporating MIDD across all development phases; ability to address dose/regimen justification and study design questions
- Hands-on experience with NONMEM and R strongly preferred
Additional Requirements/Skills:
- Strong organization, multitasking, prioritization, and ability to manage shifting responsibilities and competing timelines
- Strong interpersonal and verbal/written communication skills
- Self-motivated; able to independently manage responsibilities
- Onsite/face-to-face work essential in San Diego; not 100% remote; ability to travel
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.