Vaccines Medical Affairs Lead, Gem

Role and Responsibilities

Job purpose
- Responsible for oversight and execution of assigned regional medical tactics in collaboration with GEM, Hubs and MCO medical and cross functional organization (Market Access, Evidence Generation, Public Affairs, and relevant cross-functional teams).
- Provides up-to-date, fair-balanced product-related and clinical expertise to internal and external stakeholders as a scientific vaccine expert with focus on defined key countries.
- In partnership with TA head, establish, develop and foster relationships with key external stakeholders including Global, Regional, local levels through scientific discussions to facilitate and contribute to insight generation, publications, in-depth understanding of the populations perspective on vaccines that eventually guides the development of medical and brand plans.
- Support TA head on all matters related to medical strategy, medical governance, and compliance within the medical function, by putting the individual/population needs and safety into focus.
- Ensure compliance with regional directives for, amongst others, the release of promotional material, medical representative training materials and medical information.
- Always uphold the company reputation.

Major activities
- Ensure excellence and timeliness in implementation of the therapeutic area specific medical plans and tactics. Deploy effective measures to complete tasks within time frame.
- Co-create GEM brand plan development, in close collaboration with global, regional, Hubs and MCO, and LOC Medical Directors, TA Head and cross functional teams.
- Have a clear understanding of external stakeholder mapping, which will enable development of appropriate and relevant relationships and build networks to meet medical objectives
- Formulate strategic KOL/Stakeholder engagement plans to inform and assist in evaluating innovative ideas in development of the medical strategy and tactics
- Co-create with TA Head, drive and provide support to all the data generation activities and publications generated within GEM.
- Supports in development plan of MACS, phase III local registration clinical trials strategy. Support key countries with the development of local evidence generation activities with focus on RWE.
- Ensures the scientific integrity, GCP adherence, (global) strategic alignment and safety design of clinical studies undertaken by the regional or LOC medical affairs teams.
- Review of research proposals (include IIR, Collaborative Research, etc.) to ensure global alignment and execution of this research within Takeda standards of compliance.
- Ensure integrity and correctness of the analysis, interpretation, scientific and marketing validity of the publications produced.
- Have a clear understanding of external stakeholder mapping, which will enable development of appropriate and relevant relationships and build networks to meet medical objectives.
- Develop medical/scientific materials and slide decks as needed (e.g. Advisory board slides/symposia/scientific forum etc.) and ensure the content is appropriately reviewed and approved as per Takeda policies
- Review and approve promotional/non promotional materials per Takeda policies
- Support scientific training of medical and other internal stakeholders and provide ongoing support and education as needed.
- Develops and execute regional strategic medical communications plans in line with product/project milestones and achievements.
- Collaborates with Hubs/MCOs Medical leads and heads, and Local medical teams to build medical capabilities and to ensure strategic relevance, timeline, and delivery of medical activities.
- Develop and maintain up-to-date knowledge of the TA by reviewing the literature, engaging in ongoing scientific exchange with Key Opinion Leaders and other external stakeholders, attend relevant scientific congresses/events, including speaking and abstracts oral or poster presentations.
- Ensure that all scientific-medical communications are fair-balanced, based on appropriate scientific evidence, and compliant with local regulatory norms and internal compliance policies.
- Assist the TA head in proactive risk management and recognize when appropriate actions need to be put into place or highlighted.
- Allocate, maintains, and updates the budgets allocated to the medical activities.

Qualification and Experience
- MD (preferred) or PhD human sciences / pharmacology/Bio Sciences
- Minimum of 8 years of experience in pharmaceutical industry (including medical affairs and/or clinical development) at country and preferably above country levels
- Experiences in vaccines, infectious diseases, public health, and new product launch experiences would be asset
- Regional / international experience working in a cross-cultural environment preferred
- Good knowledge of the international public health healthcare market, able to identify healthcare trends and the related medical opportunities
- Strong planning & organization