Associate Director/Director/Senior Director, Pharmacometrics/Modeling and Simulation-REMOTE

CarterMacKay; United States; Remote; USD 150,000 - 200,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks a Director in Modeling & Simulations. This role requires strong pharmacometric skills and a deep biological understanding to lead M&S projects throughout drug development. The successful candidate will collaborate with cross-functional teams, advocate for model-based approaches, and communicate M&S results effectively. Candidates should possess a PhD in a relevant field and significant industry experience.

Qualifications

• Minimum of 8+ years of industry experience in Pharmacometrics.
• Expert skills in population-based PKPD modeling and clinical trial simulation.

Responsibilities

• Lead M&S projects for drug development programs.
• Determine and execute M&S analyses for critical decision making.

Skills

Leadership

Communication

Pharmacometric methodologies

Programming

Education

PhD in Pharmaceutics

PhD in Clinical pharmacology

Tools

NonMem

R

Phoenix

SAS

Job description

Director in Modeling & Simulations will combine strong pharmacometric skills with a deep biological understanding. They are responsible for independently determining, planning, and executing M&S analyses for an entire drug development program in close collaboration with cross-functional colleagues within the R&D organization. Specific experience and interest in working in population PK/PD or quantitative systems pharmacology is required. The Director determines, plans, and executes technically challenging analyses by using state of the art Modeling & Simulation methodologies to strongly contribute to critical decision making. The Director will lead M&S projects for an entire drug development program to evaluate study design, dose selection, probability of success estimation, portfolio strategy, pediatric extrapolation etc. In this role, it is expected that they will represent M&S with cross-functional drug development teams, proactively advocate for model-based approaches, and clearly communicate M&S results.

• • PhD in Pharmaceutics, Clinical pharmacology, or other quantitative discipline with an emphasis Pharmacometric methodologies
  • Minimum of 8+ yrs of industry experience in the application of Pharmacometrics within the context of drug development.
  • Expert hands-on skills from population-based PKPD modeling, Clinical trial simulation and optimal design, probability of success calculations, Disease progression modeling, Meta analyses etc.
  • A solid understanding of fundamental pharmacokinetic and quantitative pharmacology (PKPD) principles.
  • Excellent programming skills (NonMem, R, Phoenix, SAS and other similar tools)
  • Demonstrated strong leadership and influencing skills
  • Excellent collaborative, verbal and written communication skills
  • Experience from Regulatory interactions and guidelines relevant for M&S