3 giorni fa
Roma
EUR 90.000 - 110.000
Job Description
OBJECTIVES
* Strategic Contribution: Provide medical expertise to shape and execute Takeda’s strategy for Gastrointestinal/Inflammation Therapeutic Area and pipeline products (NPP) by collaborating cross-functionally.
* Scientific Leadership: Offer in-depth scientific insights to ensure alignment with evidence-based medicine for product development, launch, and lifecycle activities.
* Stakeholder Engagement: Strengthen relationships with key opinion leaders (KOLs), healthcare professionals (HCPs), and scientific communities to support medical strategies and advance therapeutic understanding.
* Evidence Generation: generate new clinical data and scientific evidence to support both in line/pipeline assets
* Compliance and Training: Advocate medical compliance to maintain high ethical standards and provide scientific training to internal teams (BUs and PVA) to elevate internal capabilities (scientific updates, newsletters, congress reports).
ACCOUNTABILITIES
* Medical Expertise & Strategy: Support medical strategies development and medical plans implementation across the GI portfolio to align with Takeda’s overall business objectives.
* Scientific Support: Provide medical and scientific input into clinical development plans while ensuring adherence to ethical and regulatory standards.
* Stakeholder Engagement: Build and maintain relationships with key opinion leaders (KOLs), key external experts (KEEs), DOLs (Digital Opinion Leaders), healthcare providers and academic researchers to drive awareness and credibility in GI/Inflammation TA.
* Pipeline: provide support to cross-functional launch readiness: pre-launch medical strategy, stakeholder mapping & engagement plan, insight generation, evidence generation, scientific narrative & materials readiness, medical education & training, congresses, advisory boards & expert meetings.
* Medical Education: Plan and deliver scientific training and educational programs for internal teams (e.g. Commercial and PVA) to ensure understanding/alignment on both products and therapeutic areas GI and Inflammation.
* Disclosure & Communication: Manage external communication of scientific data, including presentations at conferences, advisory boards and other scientific platforms.
* Cross-Functional Collaboration: Partner with marketing, regulatory, PVA and commercial teams to provide medical input to co-create strategies and effectively achieve GI & Inflammation TAs objectives.
* Evidence Generation: Collaborate on real-world evidence generation, R&D clinical trials (active participation in the Global Enterprise Engagement Project) and publication strategies to support Takeda’s product lifecycle management. Discuss and collect independent research proposals (IIRs) according to the company guidelines and related SOPs.
* Product Launch Activities: Provide guidance in the preparation and execution of product launches by delivering medical and scientific support while ensuring compliance with industry standards.
* PVA support: Coordinate with PVA teams both for JCA activities, product dossier submissions, providing scientific expertise and scientific documentation to ensure successful outcomes.
* Regulatory support: coordinate with the regulatory team to ensure support to regulatory activities.
* Budget: support budget management allocated to medical projects and congresses delegations according to TA medical plans and congress plans.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Education and experience
* Education requirements: Medical Degree (MD); PharmD or PhD.
* More than 3 years of experience in medical affairs roles.
* Good written and spoken English (minimum level required: Intermediate B1).
Knowledge of
* Basic knowledge of pharma industry legislation
* Drug Development and Marketing processes and requirements
* Clinical research regulatory environment, including but not limited to ICH GCP and Dir 536/2014
Technical skills
* Ability to engage with KOL community based on existing strong relationships and ability to build lasting relationships with KOLs.
* Thorough understanding of life cycle management.
* Experience with working in pre-launch phase and launch preparation.
* Ability to interpret and communicate scientific/ clinical data and collect/interpret/sharing insights.
Digital Dexterity skills
Demonstrate strong digital dexterity to amplify Medical Affairs impact using digital channels, data, and compliant technology to improve stakeholder engagement, insight generation, evidence generation, and internal scientific enablement, while ensuring privacy, security and ethical standards.
* Effectively plan and deliver scientific exchange via compliant digital channels (e.g., remote detailing platforms, virtual advisory boards, webinars, congress digital assets).
* Adapt communication style and content to channel and stakeholder needs, maintaining scientific accuracy and balance.
* Use digital tools to capture, structure, and synthesize stakeholder insights (e.g., tagging, qualitative coding, trend analysis) and translate them into actionable recommendations.
Content & knowledge management
* Develop and maintain modular scientific content and repositories (e.g., core slide decks, FAQs, congress learnings, newsletters) with clear version control and traceability.
AI literacy and practical application (within policy)
* Identify high-value use cases for AI-enabled solutions in Medical Affairs (e.g., literature monitoring, summarization support, insight triage, workflow automation) while adhering to Takeda policies and approved tools.
* Demonstrate ability to evaluate AI outputs critically (citation checking, scientific rigor) and escalate uncertainties appropriately.
Compliance, privacy, and cybersecurity
* Ensure compliant handling of scientific information and stakeholder data in all digital interactions, in line with internal SOPs, data privacy requirements and security standards.
Continuous learning & change adoption
* Proactively upskill on emerging digital platforms, field tools, and ways of working; share best practices to encourage adoption across the team.
* Demonstrate agility in adopting new processes and tools that improve execution speed, quality and collaboration.
* Strong business acumen.
* Proactive and positive work ethic.
* Ability to operate as a flexible team player.
* Ability to work in a cross-functional team and evidence of building cross-region networks.
Other
* The role will involve both national and international travel.
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