Major Responsibilities and Accountabilities
• Develops and maintains timely, scientifically sound, innovative and business-oriented M&S strategy for the projects within or across DTA in accordance with the overall DTA Clinical Pharmacology strategy defined by the DTA Clinical Pharmacologist and the DTA disease Modeling Leader
• Develops and executes appropriate (population) pharmacokinetic and (population) pharmacodynamic models for the project and applies, if available for the project, empirical and/or mechanistically-based drug disease models
• Conducts simulations to illustrate the impact of development decisions such as dosage regimen selection and other trial design features as well as reporting of the respective outcome for internal decision making or NDA documents or peer reviewed journals
• Interacts on a scientific level with the Clinical Pharmacologist with regards to all aspects of the integration of M&S to ensure efficient and appropriate M&S strategy and activities for the project
• Prepares information and strategy for presentation at pRED and PD project team meetings in order to ensure consistency of M&S activities/objectives with overall project goals and with current Roche standards
• Ensures that members of the project team and management have a sufficient understanding of the M&S methods and results appl ied to the project
• Ensures that M&S strategy and results are integrated into internal and external project documents (e.g. Clinical Development Plan, Investigator Brochure)
• Manages consultants and outside collaborators that provide M&S expertise for individual tasks or entire projects.
• Ensures that M&S activities performed within the project are executed in a timely manner and to the required high statistical, pharmacological and other reporting standards
• Medical degree or PharmD or PhD in natural science with relevant related experience in the planning and conduct of M&S projects for pre-clinical or clinical study data (preferably in a pharmaceutical industry setting)
Experience and/or Competencies Required
• Experience in planning and conduct of M&S projects for pre-clinical and clinical study data.
• Experience in M&S software NONMEM, S-Plus or R/SAS, WinNonlin, Trial Simulator (TS), and programming.
• Good knowledge of the Drug Discovery and Development process.
• Good knowledge of GCP and regulatory guidelines
• Some knowledge of clinical pharmacology and relevant biological and medical concepts.
• Highly effective team work and interpersonal skills (globally, internal and externally).
• Highly flexible with a systematic and goal oriented working style.
• Flexibility and confidence to handle ambiguities,
• changing demands and priorities.
• Ability to learn from experience – seek feedback and modify behaviour in light of feedback with adequate communication and presentation skills.
• Thinks broadly, strategically, and timely when preventing, solving or managing problems
• Flexibility and confidence to handle ambiguities, changing demands and changing priorities
• Ability to learn from experience – seek feedback and modify behaviour in light of feedback
• Highly effective verbal and written communication/ presentation skills
Roche is an equal opportunity employer.Research & Development, Research & Development > Pharmacology