Role Purpose
The senior lead, Early Pre-launch Medical Strategy is accountable for building the patient cantered early medical plans including initial Integrated Evidence Plan (IEP), and ensuring its execution, in collaboration with NPP-LEX, GDD and the medical franchise heads.
Accountabilities will involve such as (but not limited to) contribution for portfolio prioritization, an input to local target product profile (TPP), patient engagement strategy in early stages and strategic collaboration with Global team. In particular, the senior lead is required to oversight those strategic plan / execution by considering cross-therapeutic area (TA), and company-wide strategy.
Major Accountabilities
o Develop patient centered early Medical strategy and initial IEP aligned with TA strategy (local and global), including the analysis of patient needs and Healthcare system (HCS) environment.
o Act as “Medical representatives” in JPT and the agile project
o Drive the actionable insight cycle by giving regular clear direction to JPT / Pre-JBT, and utilizing the insights to update the early product strategy.
o Plan and execute initial IEP including evidence generation plan by leading cross functional team
o Plan, develop, execution and dissemination of RWE and pre-clinical research (if necessary)
o Co-generates HCS relevant data generation including implementation science in collaboration with Value & Access (V&A), Comms & Patient Engagement (PE) and GDD.
o Lead to optimize a process of initial IEP development (including project prioritization of IEP development) and its update in collaboration with MEE, V&A and GDD.
o Bring clarity to key decision making points in development process (e.g. DDP, FDP etc.) based on medical insights
o Input to local TPP optimization
o Contribute to portfolio prioritization and Japan Portfolio Review (JPFR)
Lead • Tokyo , Japan