Modeling & Simulations Associate Director

Vertex Inc.•Boston, MA

3d•$168,000 - $252,000•Hybrid

About The Position

The Modeling & Simulations Associate Director will be responsible for developing and executing M&S strategies and activities in cross functional drug development project teams in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Research and other colleagues within the R&D organization. This role determines, plans, and executes technically challenging analyses by using state of the art Modeling & Simulation methodologies to strongly contribute to critical decision making.

Requirements

A specialized understanding of biology, pharmacokinetic and quantitative pharmacology (PKPD) principles.
Excellent hands-on skills in population PK and PKPD modeling, mechanistic PKPD modeling, Clinical trial simulations, Disease progression modeling, etc.
Excellent skills in the use of NonMem, PsN, R, Phoenix, and similar tools.
Demonstrated strong leadership: collaborative and influencing skills.
Excellent, verbal and written communication skills.
In-depth experience working in clinical development teams and integrating the use of PK/PD modeling and/or modeling of complex biological system.

Responsibilities

As Modeling & Simulations (M&S) lead in one or more cross functional drug development teams, responsibilities include the development and execution of Modeling & Simulation plans and analyses fully integrated with the overall development plans.
By using state of the art Modeling & Simulation methodologies strongly contribute to critical decision making like study design, dose selection, probability of success estimation etc.
Independently perform mechanism based PKPD and population PK and PKPD-analyses, Clinical trial simulations and other model based analyses on a regular basis.
Contribute to the continuous improvement in efficiency and effectiveness of our M&S capability by supporting training activities, evaluating and incorporating new M&S tools as appropriate.