Senior Pharmacometrician (Director level) at Vertex in Boston

Senior Pharmacometrician at Vertex- (Director level) Functional Area: Modeling&Simulation, Clinical Development Location: Boston, Massachusetts Position Responsibilities: Modeling & Simulations plays an increasingly important role in the development of new drugs within Vertex Pharmaceuticals and our goal is to fully implement Model based principles to support drug development program in terms of translational modeling, clinical study design, evaluation and decision making. We are now seeking an experienced Pharmacometrician (corresponding to Director level) to our Modeling & Simulations Department to help us achieve this vision. The successful candidate will be responsible for developing and executing M&S strategies in several cross functional drug development project teams and work in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Clinical Biomarkers, Clinical Development and other colleagues within the clinical and preclinical organization. The successful candidate will play a key role in building the Pharmacometrics capability within Vertex by providing technical and strategic support to other modelers within the Department, organize training as needed and contribute to building a sustainable Modeling infrastructure. Key responsibilities: * As M&S lead in one or more cross functional drug development teams, provide modeling and quantitative expertise, develop Modeling & Simulation plans that are integrated with the clinical development plans, contribute to optimal trial design, support dose and patient selection, * Perform population PK and dose/exposure response analyses,clinical trial simulations, probability of success estimations, contribute to optimal dose selection, interact with regulatory authorities and contribute to IND and NDA filings. * Strongly contribute to the implementation of pharmacometric/modeling strategies and methodologies across projects and disease areas. * Provide technical and tactical guidance to other Modeling colleagues within the M&S department on a day-to-day basis and initiate internal training sessions in relevant areas as needed. * Establish strong relationships with colleagues within Biostatistics, Clinical Pharmacology, Clinical biomarkers, DMPK and other quantitative disciplines within Vertex. * Establish and build strong connections with M&S colleagues within top Academic institutions. * Take a leading role in the evaluation of new Pharmacometric tools and contribute to a strong and sustainable computational infrastructure for degenerative diseases. Required Qualifications * PhD (with an emphasis on pharmacometric methodologies) in: pharmacokinetics, pharmacodynamics, clinical pharmacology, statistics, bioengineering, or other quantitative discipline. * 10+ yrs hands-on experience in the application of Pharmacometric methodologies within the context of drug development. * Expert knowledge in population-based PK, PKPD, exposure/dose-response analyses, clinical trial simulation, Bayesian approaches, Meta analyses, Adaptive design etc * A solid understanding of pharmacokinetic and PKPD principles. Excellent programming skills ( NonMem, R, S Plus, SAS etc.) * Demonstrated strong experience from interactions with regulatory authorities and good insight into regulatory guidelines and expectations with respect to the use of model based methodologies in e.g. NDA filings, EoPh2 meetings etc. * Demonstrated strong leadership and influencing skills. Excellent oral and written communication skills. A demonstrated ability and aspiration to collaborate with colleagues within and outside your own discipline to reach a common goal. Demonstrated strong experience from interactions with regulatory authorities and good insight into regulatory guidelines and expectations with respect to the use of model based methodologies in e.g. NDA filings, EoPh2 meetings etc. Desirable qualifications * Experience from the application of System pharmacology in a drug development context. * ModelingExperience from disease areas like Pulmonary diseases, Oncology and Neurodegeneratve diseases Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases. If you have questions about the position, please contact Ulf Bredberg at [email protected]<mailto:[email protected]> To apply for this position please follow the link below. http://careers.vrtx.com/jobs/descriptions/modeling-simulation-director-level-boston-massachusetts-job-1-4701831 This email message and any attachments are confidential and intended for use by the addressee(s) only. If you are not the intended recipient, please notify me immediately by replying to this message, and destroy all copies of this message and any attachments. Thank you.