Role Summary
Leads medical strategy for the Rilzabrutinib launch within the Global Development Team, serving as Medical Lead on the program. Drives pre-launch medical activities and coordinates with internal and external stakeholders to develop and implement strategic medical plans during waive-1 of regulatory submissions and approvals. Reports to the Global Head of Rare Launch and Pipeline Portfolio within the Global Medical Rare Disease Organization.
Responsibilities
- Accountable for developing and implementing the Global Brand Medical strategy and action plan for Rilzabrutinib's implementation of the medical strategy globally.
- Serve as Medical representative, providing appropriate cross-functional expertise and ensuring execution of critical medical strategies within the Rilzabrutinib Global Development Team.
- Lead strategy behind the Evidence Generation Plan to support product development, working alongside the Medical Evidence Generation team, Global Product Team, and Rilzabrutinib Medical Director
- Drive the development and Global execution of the Managed Access Program for Rilzabrutinib in ITP and wAIHA.
- Define the Global strategy for Clinical Insights, KOL mapping, and Message dissemination.
- Provide Medical expertise for the design and execution of potential new clinical studies, considering clinically relevant, patient-centric outcomes.
- Lead Medical responsibilities within the Global Labelling process across Rilzabrutinib indications.
- Contribute to planning, resourcing, and budget decisions for implementing the Global Medical Roadmap for the launch of Rilzabrutinib across indications.
Qualifications
- Medical degree or PhD preferred, with expertise in Rare Hematologic Disorders
- Global and peer recognition as an opinion leader in oneβs area of expertise
- Considerable experience in evidence generation, including clinical development and/or real-world evidence (10+ years)
- Proficient in public speaking, with demonstrated facility in interacting with high-stakes external stakeholders (health authorities, scientific and medical societies)
- Demonstrated ability to work effectively and lead through influence in a matrixed environment and across geographies and cultures
- Previous experience in leading teams and budget management is preferred.