Associate Director, Pharmacometrics

Boehringer Ingelheim, founded in 1885 by Albert Boehringer in Ingelheim, Germany, began with just 28 people employed to manufacture tartaric acid salts. Now, more than 125 years later, the company operates globally with 146 affiliates and more than 47,000 employees.

Performance of high quality pharmacometric analyses on a project or study level essential for internal decision making and successful approval Authoring PMx documents (e.g. PMx report, analysis plan, dataset specification) Representation of PMx in trial teams and process harmonization initiatives/workgroups Continuous improvement of PMx infrastructure and participation in working groups

* Responsible for the timely delivery of pharmacometric analyses for internal decision making and registration (e.g. PK/PD models for dose selection, covariate analysis, simulations for labeling, simulations to optimize study designs, disease models to optimize phase III designs) * Support the project pharmacometrician (PPM) in the development and implementation of the PMx strategy and in preparing regulatory relevant documents * Responsible for the timely delivery of PMx documents (e.g. PMx report, analysis plan, dataset specification) * Representation of PMx in trial teams and process harmonization initiatives/workgroups * Continuously improve PMx infrastructure (e.g. code libraries) * Understand current national and international regulations and local requirements as well as BI policies and procedures as relevant to areas of expertise; apply knowledge to ensure safe and compliant practices, manage risk, and maximize opportunities for projects to succeed.

* PhD in Medicine, from an accredited institution, in Pharmacy, Mathematics, Biology or equivalent area of focus with at least two (2) years of relevant experience in pharmacometrics; OR Master’s degree from an accredited institution in Medicine, Pharmacy, Mathematics, Biology or equivalent area of focus with more than five (5) years; experience in pharmacometrics in the pharmaceutical industry * Demonstrated competence coding and running PMx related software (e.g. NONMEM, R, SAS) * Basic knowledge in clinical pharmacology **Skills, Experience and Abilities:** * Knowledge of and experience in application of pharmacometrics in global drug development from research to approval * Good written and verbal communication skills * Good team-worker in a multidisciplinary environment * Drive for improvement of PMx infrastructure