Associate Director, Pharmacometrics, Clinical Pharmacology
Travere Therapeutics
9 hours ago
Remote friendly (San Diego Metropolitan Area)
United States
Clinical Research and Development
Position Summary:
- Design, lead, and implement Modeling & Simulation strategies across clinical programs.
- Execute/supervise the pharmacometrics strategy with a focus on Model-Informed Drug Development (MIDD).
- Set the strategy for addressing pharmacometric issues that influence drug development decisions.
Responsibilities:
- Develop and execute modeling/simulation strategies from early through late-stage development; serve as SME in cross-functional program teams.
- Provide strategic modeling input at key development decision points.
- Set pharmacometrics issue strategy for regulatory submissions.
- Lead PMX contributions to integrate technical/scientific knowledge into quantitative development programs with focus 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 (Required):
- PhD or PharmD in Pharmaceutical Sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent).
- 4+ years relevant industry experience, including NLME methods for dose-exposure-response, population PK/PD, disease progression modeling, and clinical trial simulation.
Qualifications/Skills (Required/Strongly Preferred):
- Clinical pharmacology, statistics, and therapeutic knowledge in one or more disease areas.
- Experience incorporating MIDD into drug development across all phases (e.g., dose/regimen justification, study design).
- Hands-on experience with NONMEM and R (strongly preferred).
Additional Requirements:
- Strong interpersonal, verbal, and written communication skills.
- Ability to multitask, prioritize, and manage multiple complex tasks with competing timelines.
- Self-motivated; can independently manage responsibilities.
- Essential face-to-face function with colleagues/onsite in San Diego; not expected to be 100% remote.
- Ability to travel.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
- Design, lead, and implement Modeling & Simulation strategies across clinical programs.
- Execute/supervise the pharmacometrics strategy with a focus on Model-Informed Drug Development (MIDD).
- Set the strategy for addressing pharmacometric issues that influence drug development decisions.
Responsibilities:
- Develop and execute modeling/simulation strategies from early through late-stage development; serve as SME in cross-functional program teams.
- Provide strategic modeling input at key development decision points.
- Set pharmacometrics issue strategy for regulatory submissions.
- Lead PMX contributions to integrate technical/scientific knowledge into quantitative development programs with focus 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 (Required):
- PhD or PharmD in Pharmaceutical Sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent).
- 4+ years relevant industry experience, including NLME methods for dose-exposure-response, population PK/PD, disease progression modeling, and clinical trial simulation.
Qualifications/Skills (Required/Strongly Preferred):
- Clinical pharmacology, statistics, and therapeutic knowledge in one or more disease areas.
- Experience incorporating MIDD into drug development across all phases (e.g., dose/regimen justification, study design).
- Hands-on experience with NONMEM and R (strongly preferred).
Additional Requirements:
- Strong interpersonal, verbal, and written communication skills.
- Ability to multitask, prioritize, and manage multiple complex tasks with competing timelines.
- Self-motivated; can independently manage responsibilities.
- Essential face-to-face function with colleagues/onsite in San Diego; not expected to be 100% remote.
- Ability to travel.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.