Director, Modeling & Simulation (Pharmacometrician) at Vertex - Boston, MA | Biospace
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Director, Modeling & Simulation (Pharmacometrician) at Vertex

Vertex

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Location:
Boston, MA
Posted Date:
8/22/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Modeling & Simulation (M&S) methodologies plays an increasingly important role in the development of new drugs within Vertex Pharmaceuticals. We are now seeking an experienced M&S leader 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 the development, execution and leadership of 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
•   As M&S lead in one or more therapeutic area, responsibilities include the development and execution Modeling & Simulation plans and analyses for specific drug programs and/or therapeutic areas that are fully integrated with the overall development plans
•   Lead peers scientifically, by combining sound judgment, strong initiative and thorough methodology
•   Represent the Vertex internally and externally as the pharmacometrics expert
•   Independently perform mechanism based PKPD and population PK and PKPD-analyses, Clinical trial simulations and other model based analyses on a regular basis
•   Implement innovative study design and modeling methods to enable informed critical decision-making regarding study design elements including optimal dose selection, patient selection, trial design, sample size estimation, biomarkers and other types of quantitative decision support
•   Interact with regulatory authorities by conducting and communicating modeling results and methodologies in set timeframes, drafting regulatory response documents and participating in meetings
•   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.
•   Providing mentorship to associates

Requirements

Minimum Qualifications:
•   PhD in Pharmaceutical sciences, Pharmacometrics, Clinical pharmacology, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling
•   Ten+ 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.
•   Possesses broad experience in M&S and excellent research record in the area of M&S, such as design and analysis of nonlinear mixed models, dynamic models, mechanistic models, adaptive designs
•   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
•   Ability to collaborate extensively, as well as the ability to produce high-quality research work independently
•   Successful experience supervising Ph.D. – level scientists
•   Established track record of publications/presentations in pharmacometrics.
•   Demonstrated strong leadership-, collaborative and influencing skills
•   Excellent, verbal and written communication skills
Preferred qualifications:
•   Experience working in clinical development teams and integrating the use of PK/PD modeling and/or modeling of complex biological system