Gma Medical Lead, Pdt Innovations

vor 4 Monaten

Wien, Österreich Takeda Pharmaceutical Vollzeit

**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 GMA Medical Lead, PDT 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 product/disease area including the respective expanded access strategy

As 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 areas
- 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)
- Develop and update educational materials and assets that help differentiate SCIG products and educate on individualized treatment and related digital technologies and device innovation
- Develop TOME and educational assets to share best practices and discuss the need for IG treatment personalization.
- Internal stakeholder education on the immunoglobulin portfolio, related disease areas and device/digital 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 activities
- Global advisory boards, Steering Committees, LOC survey, 1:1 KOL engagement during congress and other F2F or virtual meetings
- Gather 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 portfolio
- Internal 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 and/or regulatory authorities as appropriate
- Input to development and management of the PDT R&D medical budget, responsibility for the product/disease area medical budget.
- Collaborates with Legal, Compliance and Regulatory to ensure proper and ethical interactions between PDT Global Medical Affairs personnel and external stakeholders
- Planning, designing and managing PDT global medical Advisory Boards as appropriate
- Providing medical review and approval of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process
- Leading design and execution of medical affairs company-sponsored and collaborative studies (phase IIIb/IV, disease registries, observational, noninterventional, epidemiological, outcomes surveys, etc.) in close collaboration with Therapeutic Area Unit representatives and Global Clinical Operations
- Monitor and communicate progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirements

**Minimum Requirements/Qualifications**:

- A medical degree (MD), PharmD, PhD or country specific equivalent is required
- Experience in launching in rare disease (i.e. neurology and/or immunology)
- At least 5 years of experience in pharmaceutical medicine/medical affairs
- 3 Years experience in global/international medical affairs
- Experience leading teams
- Clinical experience in Immunology, Neurology Hematology, Devices preferred
- Experience in field-based roles (e.g. Medical Director, Medical Science Liaison) preferred
- Experience in clinical development preferred
- Availability to travel up to 30% of time
- Som

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