Vertex Pharmaceuticals, Inc Boston , MA 02298
Modeling & Simulation methodologies 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 trial design, dose selection and to improve critical decision making.
We are now seeking to add a Scientist II to our Modeling & Simulations (M&S) group to help us achieve this vision.
The successful candidate will be responsible for executing M&S strategies in cross functional drug development project teams in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Research and other colleagues within the clinical and preclinical organization. The successful candidate will play a key role in building the Pharmacometrics and Modeling capability within Vertex by strongly contributing to the continuous improvement of our technical skill, computational infrastructure and the strategic use of M&S methodologies across our projects and disease areas.
Execute Modeling & Simulation plans fully integrated with the overall clinical plans
By using state of the art Modeling & Simulation methodologies, strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with Biostats, Clin Pharm and other quantitative disciplines
Perform population PK, PKPD-analyses, Clinical trial simulations and other model based analyses on a regular basis
Initiate and coordinate outsourced Modeling & Simulation activities when appropriate
Provide technical and tactical support to other Modeling colleagues
Strengthen our internal Modeling & Simulation capability on a continuous basis by initiating training activities, evaluating and incorporating new M&S tools as appropriate
PhD in PKPD, Clinical pharmacology, or other quantitative discipline with an emphasis Pharmacometric methodologies
3+ yrs hands-on experience in the application of Pharmacometrics within the context of drug development.
Expert hands-on skills from population-based PKPD modeling, Clinical trial simulation and optimal design, probability of success calculations, Disease progression modeling, Meta analyses etc.
A solid understanding of fundamental pharmacokinetic and quantitative pharmacology (PKPD) principles.
Excellent programming skills (NonMem, R, Phoenix, SAS and other similar tools)
Demonstrated strong leadership- and influencing skills
Excellent collaborative, verbal and written communication skills
Experience from Regulatory interactions and guidelines relevant for M&S