Le poste
04As a Translational Medicine Expert (TME) you will provide medical and scientific expertise and leadership to:
- Drive success of early global programs, develop and implement strategies to achieve Transition Decision Point (TDP)
- Drive success of late global programs by developing and implementing strategies, which lead to clinical pharmacology and profiling packages that meet regulatory requirements and support differentiated and competitive drug labeling.
- Support Translational Research in developing new indications, endpoints and biomarkers, using in vitro, in vivo, or in silico methods.
- Provide scientific expert assessments and support for in-licensing opportunities, including due diligences.
01Drive success of early global programs, develop and implement strategies to achieve Transition Decision Point (TDP)
02Drive success of late global programs by developing and implementing strategies, which lead to clinical pharmacology and profiling packages that meet regulatory requirements
03Support Translational Research in developing new indications, endpoints and biomarkers, using in vitro, in vivo, or in silico methods
04Provide scientific expert assessments and support for in-licensing opportunities, including due diligences
05Develop strategies for the Translational Medicine component of drug development projects from Research to TDP
06Act as a key leader in developing the Ph2-3 and post-approval profiling strategy for drug programs
07Provide support for dose selection, study design and other clinical pharmacology matters throughout the development cycle
08Oversee conduct and interpretation of studies prioritized by the to support the pivotal trials
09Develop strategies to identify initial or expansion (PIE) indications, and to obtain sufficient evidence to fund these ideas
10Participate on BD&L teams as the TM representative
11Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study
12Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders
13Oversee publication strategy for TM studies; lead writing of scientific publications; present study results externally where appropriate
14Lead study-specific teams/ clinical trial teams in partnership with other line functions
