Early clinical projects (Phase I / II, “Discovery”):
Develop, 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.
Late-stage clinical projects (post-TDP, “Profiling”):
In collaboration with the dermatology TA Head: Act 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. Provide support for dose selection, study design and other clinical pharmacology matters throughout the development cycle. Oversee 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.
Translational Research (TR; indication seeking, endpoint and biomarker development):
In collaboration with the dermatology TA Head, BR Research scientists, other TM line functions (BMD, CS&I, PCS, PKS), develop strategies to identify initial or expansion (PIE) indications, and to obtain sufficient evidence to fund these ideas.
Business Development and Licensing (BD&L; in-licensing and out licensing compounds):
Participate on BD&L teams as the TM representative.
General responsibilities:
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Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study.
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Provides medical and scientific leadership and expertise to all line functions on the study team.
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Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups).
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Oversee publication strategy for TM studies; lead writing of scientific publications; present study results externally where appropriate
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Lead study-specific teams/ clinical trial teams in partnership with other line functions.
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Lead BR-sub-team(s) on Global Project Teams for late-phase programs
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Collaborate 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