Modeling & Simulations Associate Director

General Summary:

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.

Key Duties and 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.

Knowledge and Skills:

• 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.

Education and Experience:

• Master's or PhD, with preference in Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling.
• Typically requires the following: PhD and 6 years experience or Master's Degree and 10 years experience in the application of Pharmacometric and other Modeling methodologies in the context of drug research & development in industry, academia or regulatory agencies.

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