Clinical Pharmacometrician
CDI Basel (Basel-Stadt) Personal services
Job description
Job facts
Within Roche pharma Research and Early Development (pRED), the Clinical Pharmacology department is committed to deliver the right dose for every patient through innovative and quantitative approaches. As a part of Clinical Pharmacology, the Clinical Pharmacometrics group integrates clinical pharmacologist data scientists and pharmacometricians for efficient, high-quality data analyses to support the decision making process from Phase I to Phase IV.
Model Informed Drug Development is at the core of Clinical Pharmacometrics and this group contributes mainly to the Clinical Pharmacology mission by developing models that integrate biology, disease and pharmacology, by using those models to predict outcome of clinical trials and design experiments that provide data to refine those models and improve their predictive power.
The pharmacometrician joining the group will have the opportunities to work in various disease areas, Inflammation, Infectious diseases, Oncology, Neuroscience and Ophthamology. In this role you will:
· Develop and maintain timely, scientifically sound, innovative and business-oriented Modeling & Simulation (M&S) strategic plan for the project.
· Develop and execute appropriate (population) pharmacokinetic and (population) pharmacodynamic models for the project and apply, if available for the project, empirical and/or mechanistically-based drug disease models.
· Conduct simulations to inform drug development decisions such as dosage regimen selection and other trial design features.
· Interact on a scientific level with partners in project team (e.g. Clinical pharmacologist, Biomarker Expert, and Translational medicine scientist) with regards to all aspects of the integration of M&S to ensure efficient and appropriate M&S strategy and activities for the project
· Integrate M&S strategy and results into internal and external project documents (e.g. Clinical Development Plan, Investigator Brochure, NDA documents)
· Who we are
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more .
Roche is an equal opportunity employer.
Desired profile
Who you are
You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You have a MD or PharmD or PhD (in natural sciences, mathematics, physical sciences or engineering or any combination of these) with relevant related experience in the planning and conduct of M&S projects for clinical study data in a pharmaceutical industry setting (3 to 4 years minimum).
In addition you bring:
· Experience with M&S software (e.g. NONMEM, Monolix, Phoenix, MATLAB, Gatroplus, Simcyp, SAS, R,…)
· Good knowledge of clinical pharmacology and Development processes
· Highly effective team work and interpersonal skills (globally, internal and externally).
· Broad, strategic and timely thinking when preventing, solving or managing problems
· Ability to learn from experience – seek feedback and modify behavior in light of feedback with adequate communication and presentation skills.
·