Senior Manager, Pharmacometrics, Clinical Pharmacology
Travere Therapeutics
2 months ago
Remote friendly (United States)
United States
$132,000 - $172,000 USD yearly
Clinical Research and Development
Position Summary:
- Design, lead, and implement Modeling & Simulation strategies across Travere clinical programs.
- Perform or supervise execution of the pharmacometrics strategy with focus on model-informed drug development (MIDD) approaches.
- Set strategy for addressing pharmacometric issues that directly influences drug development decisions.
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, well-timed modeling input at key decision points in the development path.
- Set strategy for addressing pharmacometric issues in regulatory submissions.
- Lead and drive PMX contributions to integrate technical and scientific knowledge for robust quantitative development programs focused on MIDD.
- Interpret PK/PD data using state-of-the-art modeling and simulation; ensure appropriate PK-PD analysis (population PK, PK-PD modeling/simulation, exposure-response analysis).
- Guide empirical modeling/QSP approaches 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.
- 3–6 years experience in NLME methods applied to dose-exposure-response analysis, population PK/PD modeling, disease progression modeling, and clinical trial simulation (academia and/or industry).
- Clinical pharmacology, statistics, and therapeutic knowledge in one or more disease areas.
- Experience incorporating MIDD strategies across all phases; respond to questions on dose/regimen justification and study design.
- Hands-on experience with NONMEM and R strongly preferred.
Additional Skills/Experience/Requirements:
- Embody core values: Courage, Community Spirit, Patient Focus, Teamwork.
- Well organized; ability to multitask, prioritize, and manage shifting responsibilities.
- Ability to manage multiple complex tasks with competing timelines.
- Strong interpersonal, verbal, and written communication skills.
- Self-motivated; can independently manage responsibilities.
- Essential function: able to perform face-to-face work with colleagues and/or onsite in San Diego; role not expected to be 100% remote; ability to travel.
Benefits:
- Premium health, financial, work-life and well-being offerings (for eligible employees and dependents), wellness and employee support programs, life insurance, disability, retirement plans with employer match, generous paid time off.
Compensation:
- Target base pay range: $132,000.00 - $172,000.00.
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 execution of the pharmacometrics strategy with focus on model-informed drug development (MIDD) approaches.
- Set strategy for addressing pharmacometric issues that directly influences drug development decisions.
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, well-timed modeling input at key decision points in the development path.
- Set strategy for addressing pharmacometric issues in regulatory submissions.
- Lead and drive PMX contributions to integrate technical and scientific knowledge for robust quantitative development programs focused on MIDD.
- Interpret PK/PD data using state-of-the-art modeling and simulation; ensure appropriate PK-PD analysis (population PK, PK-PD modeling/simulation, exposure-response analysis).
- Guide empirical modeling/QSP approaches 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.
- 3–6 years experience in NLME methods applied to dose-exposure-response analysis, population PK/PD modeling, disease progression modeling, and clinical trial simulation (academia and/or industry).
- Clinical pharmacology, statistics, and therapeutic knowledge in one or more disease areas.
- Experience incorporating MIDD strategies across all phases; respond to questions on dose/regimen justification and study design.
- Hands-on experience with NONMEM and R strongly preferred.
Additional Skills/Experience/Requirements:
- Embody core values: Courage, Community Spirit, Patient Focus, Teamwork.
- Well organized; ability to multitask, prioritize, and manage shifting responsibilities.
- Ability to manage multiple complex tasks with competing timelines.
- Strong interpersonal, verbal, and written communication skills.
- Self-motivated; can independently manage responsibilities.
- Essential function: able to perform face-to-face work with colleagues and/or onsite in San Diego; role not expected to be 100% remote; ability to travel.
Benefits:
- Premium health, financial, work-life and well-being offerings (for eligible employees and dependents), wellness and employee support programs, life insurance, disability, retirement plans with employer match, generous paid time off.
Compensation:
- Target base pay range: $132,000.00 - $172,000.00.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.