Associate Director, Modeling & Simulations
Vertex Pharmaceuticals
Remote
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Job Description:
Modeling & Simulation (M&S) methodologies plays an increasingly important role in the development of new drugs within Vertex Pharmaceuticals. We are seeking an Associate Director, Modeling & Simulations to add to our Modeling & Simulations group. The successful candidate will combine strong pharmacometric skills with a deep biological understanding and 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.
Key responsibilities:
- 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.
Preferred Qualifications:
- Experience working in clinical development teams and integrating the use of PK/PD modeling and/or modeling of complex biological system
Qualification:
- PhD in Pharmaceutical sciences, Pharmacometrics, Clinical pharmacology, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling
- 5+ yrs post PhD hands-on experience in the application of Pharmacometric and other Modeling methodologies in the context of drug research & development in industry, academia or regulatory agencies.
- A solid 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
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