The role
0401Drive 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 and support differentiated and competitive drug labeling.
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, in collaboration with the dermatology TA and work with teams to carry out, strategies for the Translational Medicine component of drug development projects from Research to TDP in single or multiple indications, including post-indication expansion (PIE) projects.
06Act as a key leader in developing the Ph2-3 and post-approval profiling strategy for drug programs, representing TMDP on Global Project Team (GPT) along with other TM line functions.
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, such as special populations, drug-drug interactions, mechanism of action assessments, Pediatric Investigational Plan, etc.
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.
12Provides medical and scientific leadership and expertise to all line functions on the study team.
13Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups).
14Oversee publication strategy for TM studies; lead writing of scientific publications; present study results externally where appropriate.
15Lead study-specific teams/ clinical trial teams in partnership with other line functions.
16Lead BR-sub-team(s) on Global Project Teams for late-phase programs.
17Collaborate closely with other TM (especially CS&I) and non-TM (especially Project Management) line functions to ensure operational excellence, continued urgency, and close attention to timelines, costs, and subject burden in balance with high scientific standards and innovation.
