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| Group Head, Modeling & Simulation - Oncology |
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The Group Head, Modeling & Simulation - Oncology will be responsible for the following areas:
Influence development of well-focused, efficient trial designs and drug development strategies in the oncology area through the use of Modeling and Simulation (M&S) and Computer Aided Trial Design (CATD) within the context of Clinical and Project teams, in interfacing and collaborating with the Biostatistics department
Supervise, coach and develop M&S scientists, provide expertise in M&S, develop Clinical Trial Simulation platform
Support Clinical teams and Projects in recommendations and decision-making processes, facilitate communication with Supervisory Committees, Management, Health Authorities, and other stakeholders
Our preference is for this position to be based in Darmstadt - Germany, however, we would also consider applicants wanting to be based in Geneva.
Main Tasks & Responsibilities :
Management :
Supervise and manage staff and take responsibility for deliverables in the oncology field, including M&S strategies, analysis plans, reports, presentations and recommendations, and CATD plans and reports
Oversee contract research organizations on deliverables if work is outsourced
Provide technical input to M&S staff responsible for the analysis and interpretation of PK/PD data
Functional Knowledge :
Provide extensive expertise in the use of Population PKPD Modeling and ensuing Simulations
Contribute to the integration of PK, biomarkers/PGx and surrogate endpoints in study design, analysis, interpretation and reporting
Provide M&S expertise in Exploratory or Confirmatory Trials designs elements aimed at linking ultimate Clinical endpoints to the drug pharmacokinetics and biological activity
Provide PK/PD and CATD expertise to support design choices for individual studies and across drug development projects, primarily in the oncology area
Provide support to advanced population PKPD modeling, with emphasis on mechanistic approaches
Provide support in developing models of Disease Progression, and their integration into Development Plans
Provide support to characterize relationships between drug exposure and effects, taking appropriate covariates into account, through innovative clinical trial designs
Aggregate disease and population understanding, drug candidate properties, and PKPD models capabilities and limitations, to quantify uncertainty and risk associated with the development strategy, for input into Clinical Development Plan
Promote model-based drug development by integrating M&S methodology into early and full Clinical Development Plans
Provide support to Project Teams and Management in decision-making, through M&S methods, by improving understanding, interpretation and comparison of the PK and PD of drugs in development
Provide expert input in transactions with Health Authorities for matters related to Development plans and Trials design, analysis or interpretation involving M&S
Ensure support and provide guidance for the installation, qualification, validation and maintenance of the software and technological platform necessary for proper implementation and use of Population-PK/PD based Modeling & Simulation and Clinical Trial Simulation
Keep up-to-date with current developments in M&S literature, current issues and hot-topics, attending appropriate training, symposia or conferences; participating in these and presenting where appropriate
Leadership:
Promote, educate and mentor M&S scientists, biostatisticians, clinical pharmacologists, as well as other clinical development stakeholders, in the proper uses of M&S techniques by sharing best practices and experiences, providing consultancy and technical input
Prepare and deliver training materials on advanced PK/PD M&S techniques and Clinical Trial Simulations
Promote M&S methodologies as well as Computer Aided Trial Design methods at internal and external meetings |
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Bachelors Degree
Doctorate
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7 years + |
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French : Speak Well
German : Speak Well
English : Speak / Write Fluently
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open-ended |
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unspecified |
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International |
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Geneva |
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PhD or equivalent degree in Clinical Sciences related disciplines (Medicine, Physiology, Pharmaceutical Sciences, …) and strong expertise in Pharmacometrics/biostatistics
Alternatively, MSc/PhD in Biostatistics and strong experience in clinical development involving producing simulations for assessing clinical trial designs
Fluent in English (written & spoken)
Good knowledge in French and/or German is an asset
Professional Skills & Experience :
6+ years experience in PKPD Modeling, of which 4+ in BioPharmaceutical Industry
PKPD M&S input into drug development
Experience/expertise in NONMEM, WinNonLin, SAS and S-PLUS is essential
- Experience with CTS (Clinical Trial Simulation) or other CATD software is an asset
- Additional experience with ADAPT, SAAM II and other analyzing/modeling/presentation software or language is another asset
-Experience in writing and using PKPD models, particularly mechanistic-models
-Experience in developing disease progression models is an asset
-Overall good knowledge of common PC software
Strong problem solving skills and ability to analyze complex problems
Enthusiastic, self-motivated. Excellent communication skills.
At ease in working in a dynamic matrix organization
Able to communicate technical details effectively between scientists, clinicians and statistical colleagues |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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