As 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.
Responsibilities
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.
Develop 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.
Act as a key leader in developing the Ph2-3 and post-approval profiling strategy for drug programs.
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.
Develop strategies to identify initial or expansion (PIE) indications, and to obtain sufficient evidence to fund these ideas.
Participate on BD&L teams as the TM representative.
Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study.
Provide medical and scientific leadership and expertise to all line functions on the study team.
Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders.
Oversee publication strategy for TM studies; lead writing of scientific publications; present study results externally where appropriate.
Lead study-specific teams/ clinical trial teams in partnership with other line functions.
Collaborate closely with other TM and non-TM line functions to ensure operational excellence.
Requirements
Doctoral degree, MD
Board certified Dermatologist
Preferably Ph.D. within dermatology/immunology
At least 5 years’ experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience.
Seeks out new clinical discovery opportunities and approaches to reach TDP.
Recognized expert in field, driving success for individual studies and projects; respected by colleagues across R&D, Development, and externally.
