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Major Responsibilities and Accountabilities:
Accountable for the scientific and technical quality and the timeliness of the pharmacometric (i.e. Modeling and Simulation - M&S) support provided for development projects within one or several Disease Translational Areas (DTA) by integration of scientific knowledge from literature and pre-clinical and clinical studies into mathematical models, in order to support optimal decision making in drug development from exploratory phase to confirmatory phase. Additionally, the position offers professional latitude to allocate dedicated time toward methodological innovation, evaluation of new modeling techniques, and standard process optimization to expand functional modeling excellence. For candidates with strong background or interest in clinical pharmacology, a dual-role framework can be customized.
• 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 applied 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
• Develops and maintains specific scientific expertise in new and emerging areas of Pharmacometrics. Establishes and manages external contacts and alliances in this field and ensures that knowledge for the assigned areas is shared effectively throughout the department.
• Provides mentorship and scientific and professional leadership to other members of the Clinical Pharmacology department.
• For candidates with strong background or interest in clinical pharmacology for local and global, a dual-role framework can be customized.
Qualifications:
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
• Other (valuable, but not mandatory):
· Expert in clinical pharmacology and relevant biological and medical concepts
· Strong track record of high standard publications in the field of M&S
· Effective leadership skills including ability to motivate people and delegate tasks for quality results and managerial skills.
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Roche is an Equal Opportunity Employer.