769 million patients were impacted by Novartis products in 2020. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
The U.S. Regional Medical Director, RLT role will have both internal and externally facing responsibilities to execute RLT medical strategy developed in close collaboration with US HQ Medical teams. Clinical development teams and Pipeline teams. They will work closely with HQ teams on Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use). The U.S. Regional Medical Director, RLT will also work closely with cross functional teams to expand RLT platform.
Your responsibilities include, but are not limited to:
* Provide medical and patient care education (as appropriate) to external key stake holders on pipeline, marketed compounds and RLT requirements.
* Extensive interactions with academic thought leaders to optimize clinical trial strategies, as well as extensive interactions with other functional teams including HEOR, Medical Information, Scientific Communication, Commercial, Regulatory and others, to refine compound strategy and projects.
* Working closely with Disease Medical Teams, review and provide US feedback to Global Protocols and Global Development Plans. Develop strategy for US Medical Affairs including exploratory indications and integrate US plan with overall Global Medical Affairs strategy.
* Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards including: o Write and/or review protocols that are in-line with the overall indication strategy within RLT space. o Conduct medical review and interpretation of efficacy and safety data from clinical trials.
* Work with Clinical Team and other functions to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (i.e. IB, IND sections), for Company Sponsored project. Review and approve abstracts publications & manuscripts for Investigator Initiated Trials to ensure clinical accuracy and appropriate safety review. Present and discuss data and findings at relevant internal and external meetings.
* Ensure adherence to GCP/ICH and company Standard Operating Procedures (SOPs).
* Aligning with IDMTs/Disease area teams to: o Ensure delivery of US medical tactical plan and development activities across all of a compound's related to the disease area, cost, time and quality. o Collaborate and work with other USOM line functions for data gaps analysis, data generation activities, strategic congress management, strategic trial management, external partner management and launch readiness plans. o Provide strategic input into Clinical trial design and methodology.
* Support and participate in FDA meetings including presentations, briefing books, and responding to FDA inquiries as needed. Assist in the development and appropriate spending of clinical budget and coach and train internal colleagues as requested