International Medical Affairs Director, Evidence Generation

International Medical Affairs Director, Evidence Generation

Kyowa Kirin International

Marlow, United Kingdom

This role will be critical in creating and supervising delivery of evidence generation plans, which reflect prioritized needs from across the International markets and contribute to the future strategic development of the Metabolic Bone Disease Franchise. The role will also ensure creation and management of appropriate registries and publication plans and manage the process for approval and support of Investigator Initiated Studies.

Key responsibilities:

  • Liaise with Medical Affairs teams within major International Markets, to manage an annual process to identify data gaps and evidence generation opportunities which will enable and enhance market access, payer support, expert endorsement and successful commercialization of burosumab;
  • Create propose and secure approval of Annual Evidence Generation Plan to include:
    • A strategic overview of evidence generation needs in relation to burosumab Lifecycle Strategy, identifying gaps and providing context for new study proposals;
    • Prioritized or approved new study concepts, outline protocols, budget and timelines for proposed studies;
    • Study protocols, recruitment status, projected timelines and costs of ongoing studies;
    • Approved IIS protocols, including status, budgets and timelines (ongoing and proposed);
    • The Early Access Programs and the XLH Patient Registry, including status and budget requirements.
  • Manage and develop the existing Patient Registry for subjects with XLH;
  • Manage and develop the existing Early Access Programs for burosumab in EMEA, and develop plans for potential extension of the program to adult patients;
  • Manage the process of assessing external study proposals (Investigator Initiated Studies) to secure input from relevant internal experts and support the approval decision-making process and financial management of the approved elements of the final budget, in support of:
    • Furthering understanding of the science of the underlying disease;
    • Furthering understanding of optimal disease management throughout the natural history of the disease;
    • Establishing the optimal role for KRN23 in XLH disease management.

Key requirements include:

  • Extensive iexperience industry experience, with previous experience in rare diseases and orphan drugs preferred;
  • Relevant scientific degree or appropriate certification, with medical qualification preferred;
  • Significant experience as ABPI medical signatory preferred;
  • Comprehensive understanding of industry medical governance norms, particularly with reference to compliance with all laws, regulations and industry codes of practice;
  • Exceptional track-record of success in clinical study design, planning and operational delivery;
  • Demonstrated ability to interact constructively and productively with affiliates and internal functions critical to the delivery of clinical evidence;
  • In-depth knowledge of the bone metabolism disease area;
  • In-depth understanding of the patient journey, treatment guidelines, issues and controversies relevant to optimal management of Metabolic Bone Disease and XLH;
  • Line management experience preferred.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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