Global Medical Affairs Lead, Plasma-Derived Therapies ...

About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as Global Medical Affairs Lead, Plasma-Derived Therapies Innovations where you will lead development and execution of multi-year global medical strategy for Innovations (Devices & Digital Assets), appropriately aligned with overall strategy and incorporating PDT R&D functional strategies including clinical, regulatory, GEO, safety, compliance. Lead development and execution of multi-year global medical strategy for Device and Digital innovations with an extends to current PID focus and into other therapeutic areas within the SID and CIDP areas.You will also lead scientific communication and education strategy e.g. publications strategy, congress strategy, HCP interaction strategy, and the scientific communication platform for the disease area brand(s). Serve as the global expert within PDT in support of the productdisease area including the respective expanded access strategyAs part of the PDT Medical Affairs team, you will report to the Therapeutic Area Head Immunology and work with stakeholders across the global organization.How you will contribute:Lead development and execution of multi-year global medical strategy for Device and Digital innovations with an extends to current PID focus and into other therapeutic areas within the SID and CIDP areasLead scientific communication and education strategy e.g. publications strategy, congress strategy, HCP interaction strategy, and the scientific communication platform for the disease area brand(s)Develop and update educational materials and assets that help differentiate SCIG products and educate on individualized treatment and related digital technologies and device innovationDevelop TOME and educational assets to share best practices and discuss the need for IG treatment ternal stakeholder education on the immunoglobulin portfolio, related disease areas and devicedigital innovation by leveraging Takeda Plasma University and other educational platforms.Collect insights on needs and gaps related to treatment burden and feedback on new devices and digital solutions to inform data generation and educational activitiesGlobal advisory boards, Steering Committees, LOC survey, 1:1 KOL engagement during congress and other F2F or virtual meetingsGather internal insights from LOCs, regions, and functions through surveys, GCMU, and 1:1 to inform global medical strategy.Builds and manages purposeful relationships with external stakeholders including KOLs, Scientific Societies, CoEs and patient advocacy groups. Strong relationship building due to the need to cross TA collaborations for innovations that spans across the portfolioInternal capacity building: scientific training strategy and execution appropriately aligned with overall strategy and incorporating R&D and cross-functional strategies including clinical, regulatory, GEO, safety, compliance.Acts as a senior company representative interacting with external scientific leaders, patient organizations, scientific societies andor regulatory authorities as appropriateInput to development and management of the PDT R&D medical budget, responsibility for the productdisease area medical budget.Collaborates with Legal, Compliance and Regulatory to ensure proper and ethical interactions between PDT Global Medical Affairs personnel and external stakeholdersPlanning, designing and managing PDT global medical Advisory Boards as appropriateProviding medical review and approval of Investigator Initiated Research (IIR) proposals and other grants through the grant approval processLeading design and execution of medical affairs company-sponsored and collaborative studies (phase IIIbIV, disease registries, observational, noninterventional, epidemiological, outcomes surveys, etc.) in close collaboration with Therapeutic Area Unit representatives and Global Clinical OperationsMonitor and communicate progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirementsMinimum RequirementsQualifications:A medical degree (MD), PharmD, PhD or country specific equivalent is requiredExperience in launching in rare disease (i.e. neurology andor immunology)At least 5 years of experience in pharmaceutical medicinemedical affairs3 Years experience in globalinternational medical affairsExperience leading teamsClinical experience in Immunology, Neurology Hematology, Devices preferredExperience in field-based roles (e.g. Medical Director, Medical Science Liaison) preferredExperience in clinical development preferredAvailability to travel up to 30% of timeSome activities may call for early or late meetings and attendances at scientific meetings on holidays and weekends

Created: 2024-11-17