Senior Pharmacometrician

Major Responsibilities：

• Develops and maintainstimely, scientifically sound, innovative and business-oriented M&S strategic plan for the project within pRED China inalignment with the overall M&S strategy defined by the Global  M&S Cluster Heads and  Translational Disease Modeling Experts for Oncology and Virology.
• 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.
• EnsuresthatmembersoftheprojectteamandmanagementhaveasufficientunderstandingoftheM&Smethodsandresultsappliedtotheproject by
• Interacting on a scientific level with partners in the pRED project team (Clinical Pharmacologist, Project Leader, Biomarker Expert, and Translational Medicine Leader) with regards to all aspects of the integration of M&S to ensure efficient and appropriate M&S strategy and activities for the project.
• Interacting on an operational level with the Clinical Operations Leader and Project Data Manager with regards to all aspects of the implementation of Modeling and Simulation to ensure efficient and appropriate support to the project M&S activities.
• Prepares information and presents strategy 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 and integrates M&S strategy and results into internal and external project documents (e.g. Clinical Development Plan, Investigator Brochure)
• 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.
• Participates, in pRED project teams to represent In Silico activities (preclinical and clinical M&S, Bioinformatics and Imaging)
• Establishes, promotes and maintains effective working relationships with other Roche stakeholders, departments and functions as required.Manages consultants and outside collaborators that provide M&S expertise for individual tasks or entire projects. Acts as liaison between external contractor and team.
• Builds an exemplary reputation for M&S both internally and externally including links with key opinion leaders as required by
• establishing and managing external contacts and alliances in this field and ensuring that knowledge for the assigned areas is shared effectively throughout the department,
• developing and maintaining specific scientific expertise in new and emerging areas of pharmacometrics,
• leading or contributing to expert working groups within the M&S department as well as
• leading cross-functional working groups regarding pharmacometric topics with the aim to establish guidance’s and best practices for efficient implementation of new methodologies and processes.
• Provides mentorship and scientific and professional leadership to other members of the Modeling and Simulation department.

Requirement：

• MD or PharmD or PhD in natural science with relevant related experience in the planning and conduct of M&S projects for clinical study data in a pharmaceutical industry setting (4 to 5 years minimum)
• Significant relative experience in M&S software NONMEM, S-Plus or R/SAS, WinNonlin, Trial Simulator (TS), and programming.
• Significant relative experience of clinical pharmacology and relevant biological and medical concepts.
• Expert in clinical pharmacology and relevant biological and medical concepts.
• Expert knowledge of the drug development process including GCP and regulatory guidelines.
• Highly effective team work and interpersonal skills (globally, internal and externally).
• Willingness to travel internationally and work across cultures.
• Highly effective verbal and written communication/ presentation skills
• Other (valuable, but not mandatory):
• 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.