Therapeutic Area Lead

**OBJECTIVES**:

- Responsible for developing and managing the medical strategy for specific therapeutic areas (TA)/ brands and integration of this strategy into the brand plan\s.
- In-house scientific expert for the specific TA continually reviewing relevant and current scientific literature and providing up-to-date, fair-balanced product-related and clinical information relevant to the TA to internal and external stakeholders.
- Establish, develop and foster relationships with key external stakeholders through scientific discussions to facilitate and contribute to insight generation, in-depth understanding of the patient journey within specific therapeutic areas (TA) that eventually guides the creation of the medical plan which enables greater access and capability building across the treatment pathway.
- Assist the Head Medical Affairs in all matters related to medical governance and compliance within the medical function, by putting the patient’s needs and safety into focus.

**ACCOUNTABILITIES**:
Key Opinion Leader (KOL) engagement, partnerships with professional societies & Non-Government Organisations (NGOs)

Education and training initiatives enabling early disease identification and optimal management to improve Standards of Care (SoC)

Deliver medical / scientific messages relating to product data and disease to selected KOLs identified through stakeholder mapping and according to defined stakeholder engagement plans.

Partnerships and scientific support to develop Centres of excellence (CoE)

Global partnerships through preceptorships, & scientific engagements to enhance skills and capability across the healthcare system

Clinical trial opportunities to drive early experience and advance patient access to medicine pre-registration

Support and drive Real world evidence (RWE) data generation (internal and external data)

Contributing to the organization through medical expertise:

- Ensure excellence and timeliness in implementation of the therapeutic area specific medical plans
- Establish scientific engagement plan aligned with the TA medical Plan to guide in-field activities (e.g. scientific platform content, presentation of new data)
- Formulate strategic KOL/Stakeholder engagement plans to inform and assist in evaluating innovative ideas in development of the medical strategy
- Evaluate execution of plans on an ongoing basis and adapt where necessary to improve
- Respond to unsolicited requests from Health Care Professionals (HCPs) for medical information (including off-label information) related to marketed Takeda products and Takeda pipeline products
- Review and approve promotional materials as per Takeda policies
- Develop medical/scientific materials and slide decks as needed (e.g. Advisory board slides) and ensure the content is appropriately reviewed and approved as per Takeda policies
- Support scientific training of internal stakeholders and provide ongoing support and education as needed

Building capabilities:

- Develop and maintain up-to-date knowledge of the TA by reviewing the literature, engaging in ongoing scientific exchange with KOLs and other external stakeholders, attend relevant scientific congresses
- Develop a TA specific scientific engagement plan aligned with the TA medical Plan to guide in-field activities (e.g. scientific platform content, presentation of new data)
- Deploy effective measures to complete tasks within time frame
- Collaborate and participate in cross functional teams to work towards achieving objectives set out in brand plans at a local and regional level where required.

Managing and Engaging External Stakeholders:

- Have a clear understanding of external stakeholder mapping, which will enable development of appropriate and relevant relationships and build networks to meet business objectives
- Work with key stakeholders to gain a comprehensive understanding of the patient journey and how it may evolve in the future
- Drive Scientific leadership through facilitation of meetings & events with clinical experts to strengthen capacity, improve referral pathways and provide higher quality of care
- Be customer centric in all actions, listening to spoken and implied feedback and responding in a timely manner

Complying with external regulations and company policies for a best-in class medical contribution for the patients and TA:

- Have a good understanding of global and local regulations and company policies and how to conduct all activities within that framework
- Ensure that all scientific-medical communications are fair-balanced, based on appropriate scientific evidence, and compliant with local regulatory norms and internal compliance policies
- Prioritize patient safety by following all Pharmacovigilance (PV)-related processes
- Assist the Medical Affairs Head in proactive risk management and recognize when appropriate actions need to be put into place or highlighted
- Uphold the Company’s reputation at all times

Responsibilities relating to