Translational Medicine Director​/Associate*- Cardiovascular & Metabolic

Summary

Novartis Bio Medical Research (BR) 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 Novartis  , 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.

Novartis Bio Medical Research (BR) 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 Novartis  , 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.

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-mechanism and proof-of-concept (PoC) in patients, as well as support for later 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 early clinical trials led by our translational medicine experts are among the most critical steps in drug development er 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.

Oversees the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations, serving a leadership role in the matrixed trial team. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements

• 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
• Responsible for clinical portions of the Integrated Development Plan (IDP) through PoC.
• Acts as medical monitor for one or more clinical studies.
• Communicate clinical team matters to project teams and relevant decision boards (such as the Disease Area Decision Board).
• Convene relevant (internal and external) leaders to consider proposed approach to PoC.
• Evaluate clinical centers and foster communication with crucial collaborating investigators.
• Oversee publication and external presentation of PoC clinical study results.
• Accountable for compound related biomarker strategies; work closely with biomarker experts in implementation.
• In collaboration with research scientists identify, develop and implement strategy for preclinical support of program related objectives; this includes…