253M people worldwide are visually impaired of which 80% can be prevented or cured. Novartis is reimagining the treatment and prevention of visual impairment and blindness. We aim to develop life-changing pharmaceuticals and transformative technologies for diseases and conditions from front to back of the eye. NIBR's Ophthalmology group is working on treatments for the leading causes of blindness as well as cell and gene therapies for rare diseases, a new frontier in medicine that can enable us to transform eye care for patient.
The Translational Medicine (TM ) Discovery & Profiling (TMDP) group is a team of physicians and clinical researchers who drive that innovation science from discovery to the patient through the selection, profiling and effective development of medicines.
In the role of Ophthalmology (OPHTHA) TM Expert you will develop high value decision-strategies for the Translational Medicine component of drug development projects through the PoC phase.
Your main accountabilities will include but not be limited to:
* Lead global project teams to develop clinical strategy and drive implementation of clinical development plan, providing medical and scientific leadership and oversight; participate in project teams through program life cycle from New Target Review Committee (NTRC) stage to registration. * Be responsible for clinical portions of the Integrated Development Plan (IDP) * Implement studies from First-in-man to Proof of concept phase . This may include methodology studies to identify and validate novel endpoints for early decision making in PoC studies. * Present clinical strategy to to relevant Decision Boards (e.g. DADB, TED). * Work closely with Biomarker Expert to develop and implement compound related biomarker strategies in implementation. * Collaborate with research scientists to identify, develop, and implement strategy for preclinical support of program-related objectives. This includes assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications, and other relevant activities. * Contribute to Health authority interactions and documents as TM Expert