Cardiovascular Translational Medicine Expert (Director/Exec Director)

The number 1 cause of death in men and women globally is cardiovascular diseases, taking an estimated 17.9 million lives each year (nearly a third of all death). Novartis is committed to developing transformative treatments for cardiovascular and metabolic diseases, including heart failure, arrhythmias and atherosclerotic cardiovascular disease, as well as diseases across a wide range of therapeutic areas.<br><br>The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis that collaborates across the company and beyond, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 900 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application.<br><br>The TM Discovery & Profiling (TMDP) is a group of physicians and clinical researchers who drive innovative science from discovery to the patient through the selection, profiling, and effective development of medicines. Translational medicine experts oversee Phase 1 and 2 clinical trials to demonstrate proof-of-concept (PoC) in patients, as well as support for Phase 3 development. Translational medicine experts are key and highly visible members of global cross-functional project teams that design and implement early research and discovery projects that then culminate in clinical PoC studies. Translational medicine experts collaborate with colleagues in biology and chemistry to identify targets in diseases with significant unmet medical needs and provide input on likely clinical development pathways. The PoC studies led by our translational medicine experts are among the most critical steps in drug development at Novartis. After PoC and if the program proceeds to full development, the translational medicine expert continues as a key member of the full development team up to and including registration.<br><br>As a Cardiovascular Metabolism (CVM) Profiling TM Expert, you will collaborate with the CVM TM Head or other experienced TM Expert to develop high value decision-strategies for the Translational Medicine component of drug development projects and lead global cross-functional project teams through the PoC phase and beyond. You will be responsible for implementation of strategies for assigned drug development projects in liaison with appropriate line functions and leading to clinical pharmacology and profiling studies that meet regulatory requirements (ICH/GCP, Novartis SOPs/NIPs).<br><br>Your main accountabilities will be:<br><br>• Lead global project teams through PoC phase to drive implementation of the PoC strategy; participate in project teams through program life cycle from NTRC to registration.<br>• Responsible for clinical portions of the Integrated Development Plan (IDP) through PoC.<br>• Responsible for implementation of studies during the PoC phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in PoC studies.<br>• Act as medical monitor for one or more global clinical studies.<br>• Communicate clinical team matters to project teams and relevant Decision Boards (DADB).<br>• Convene relevant (internal and external) leaders together to consider the proposed approach to PoC.<br>• Evaluate clinical centers and foster communication with crucial collaborating investigators.<br>• Oversee publication and external presentation of PoC clinical study results.<br>• Accountable for compound related biomarker strategies; works closely with Biomarker Experts in implementation.<br>• In collaboration with research scientists, 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.<br>• Participate in team presentations to health authorities as the TM expert.<br><br>Position can be based in Basel, Switzerland or Cambridge USA. <br><br>[#video#https://www.youtube.com/embed/Mo1vwtVPVA0{#400,300#}#/video#]