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RMD/Immuno Medical Lead

Apply Now Email Me Job ID R0013363 Date posted 10/16/2019 Location: Rome, Italy

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Job Description

Job Title: RMD/Immuno Medical Lead

Department: Medical & Regulatory

The position reports to: Medical & Regulatory Director

Scope:

  • Provide medical expertise and support for Therapeutic Area(s) (TAs)/Takeda products with responsibility to Market Access, Brand Management / Marketing & KAMs and other internal stakeholders
  • Ensure the correct interpretation and communication of scientific data of Takeda products
  • Play a role of advocate for patients needs
  • Assist with launch of new Immunology and Rare Disease products in the market

    Responsibilities:

  • Medical/Scientific Affairs
    • Present the clinical evidence to internal and external stakeholders in a non-promotional way, e.g. advisory boards, while determining their needs as well as patient needs in order to become a partner in improving health care 
    • Assess scientific accuracy and validity of non-promotional material and its compliance with Takeda standards, SOPs and national laws
    • Communicate and align with Regional and Global Medical Affairs functions, as well as with other LOC functions (e.g. Commercial, Market Access) to ensure alignment in meeting customer needs
    • Implement local strategic medical plans in line with product Life Cycle Management plans and oversee execution (including the production of local publications, planning and conduct of local Advisory Board meetings etc.)
    • Establish and maintain strong relationships with Key Opinion Leaders (KOLs), understand their needs creating a medical strategy and tactics accordingly
    • Act as a communication link to authors of scientific publications about Takeda products
    • Provide extensive, clear and structured briefing to external presenters/speakers at Takeda sponsored medical events (e.g. local Advisory Boards, doctors’ meetings)
    • Support the LOC Management in Identifying gaps in the local clinical study program which are a hurdle for successful regulatory and/or clinical acceptance of the product and propose studies to address these issue
    • Provide medical expertise to LOC Market Access, (e.g. Pricing & Reimbursement Dossier creation)
    • Provide medical expertise to LOC Regulatory Affairs/LOC Pharmacovigilance/LOC Quality Assurance
    • Evaluate and support local investigator-initiated research proposals in alignment with global strategy and Takeda standards and SOPs
    • Provide medical training for allocated therapeutic area / products to Marketing & Sales

  • Clinical Development
    • Support the Medical Lead to develop study outline and protocol for local post-authorization (phase 4) and other Real-World Evidence (RWE) studies sponsored by Takeda; coordinate/oversee study conduct, data analysis and disclosure, reporting/publication
    • Collaborate with Global Development Operations functions (e.g. LOC Support)

Key Capabilities:

  • University degree Medicine, mandatory
  • Therapeutic Area experience as a specialist or for previous professional experiences
  • More than 3 years of experience in Pharma medical roles
  • Ability to engage with KOL community based on existing strong relationships and help to build lasting relationships with KOLs
  • Business acumen defined as a mix of strategic industry insights, cross functional understanding mixed with appreciation of regulatory needs and clinical experience
  • Possibly experience with new product launches
  • Good written and spoken English (Level B1)

Locations

Rome, Italy

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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