Senior Manager, Pharmacometrics, Clinical Pharmacology
Travere Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: San Diego • California • United States
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Salary
💰 $132,000 - $172,000 per year
Job Level
About the role
- responsible for the design, leadership, and implementation of Modeling & Simulation strategies across Travere clinical programs
- perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches
- set the strategy for addressing pharmacometric issues and directly influences drug development decisions
- developing and executing modeling and simulation strategies from the early through late-stage clinical development
- serve as the SME in cross-functional development program teams
- play a key role in delivering strategic and well-timed modeling input at key decision points along the development path
- set the strategy for addressing pharmacometric issues in regulatory submissions
- lead and drive PMX contributions to integrate technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies
- use state of the art modeling and simulation approaches to interpret PK/PD data
- guide empirical modeling/QSP approaches to understand relationship between PK, biomarkers and disease outcomes
Requirements
- PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent)
- 3-6 years experience in NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation in academia and/or industry
- Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas
- Experience with incorporation of MIDD strategies into drug development across all phases and responding to questions on dose and regimen justification, study design among others
- Hands-on experience with at least NONMEM and R is strongly preferred.
Benefits
- premium health
- financial offerings
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
modeling and simulationpharmacometricsNLME methodspopulation PK/PD modelingdose-exposure-response analysisdisease progression modelingclinical trial simulationempirical modelingQSP approachesMIDD strategies
Soft Skills
leadershipstrategic planningcross-functional collaborationcommunicationinfluencing decisionsproblem-solvingtimelinessscientific knowledge integrationguidanceexecution
Certifications
PhDPharmD