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 Head, RLT Regional Medical Directors Team is responsible for leading a team of Regional Medical Directors covering multiple therapeutics areas as well as RLT platform within US. This role will have both internal and externally facing responsibilities to execute RLT medical strategy developed in close collaboration with US HQ Medical teams.
This position requires strategic decision-making, and effective and compliant leadership of initiatives in alignment and/or collaboration with multiple cross-functional stakeholders (e.g. Commercial; Field Market Access, Medical Franchise Heads, Disease team Leads; Head Field MSL teams, Scientific Strategy and Content Director (SSC), Data and Digital, Strat and Ops, Managed Markets Field Medical, Clinical Operations, Medical Account Engagement, Franchise Strategy and Communications Director and Field Medical Territory Lead).
Your responsibilities include, but are not limited to:
* In partnership with the Disease Area Lead define and lead national, regional and state medical strategy across Radio ligand therapy platform for Disease areas of interest, and pipeline research. Development of strategy for placement of research with key institutions.
* Co-lead the strategy for leadership engagement of key academic institutions, and research centers, and other external stakeholders. 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.
* Ensure adherence to GCP/ICH and company Standard Operating Procedures (SOPs).
* Aligning with Disease 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. Manages field medical analytics and metrics and reassesses field medical resources per franchise to ensure and/or maximize business outcomes.
* Ensures team training/readiness. Leadership and people management across Regional Medical Directors Team, including performance management, coaching and mentoring, growing and developing talent and building high performing teams.