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Shire Global medical lead in Zug, Switzerland
Located in Zug, Switzerland, the medical lead will report to the Global Medical Franchise Team Lead in Global Medical Affairs (GMA) and work closely with the global cross-functional
stakeholders within the franchise. The Associate Director will be a key contributor to maximizing the value of the current and future Hemophilia portfolio and will specifically focus on one medical device. He/She will support the execution of key medical affairs activities according to the Global Medical Affairs strategy for a medical device in the Hemophilia franchise in close collaboration with the countries and key functions and will lead global scientific programs, tactics and clinical activities. He/she will be a key contributor to the development, launch preparation and life cycle management of a medical device and medical software.
The Associate Director will support development, launch planning and roll out and life cycle management of the medical device for the hemophilia products, including all activities related to this device (eg, support of RA filing, country support, training and communication)
He/She will support the pediatric validation study of the device with global clinical development
He/She serves as scientific resource to the device core team in support of medical/scientific, regulatory, and communication strategy development and execution
He/She decides on the launch strategy, communication and country support in agreement with the Global Medical Team Lead and Marketing/Market Access partner
He/She supports of the AHEAD registry in relation to the device data management and support of the device pediatric validation study in close collaboration with the global clinical development team
Education and Experience Requirements
Advanced scientific degree (MD, PhD or PharmD)
Experience or training in Hematology and bleeding disorders
Knowledge and experience in medical device development process and medical software development
Biostatistics knowledge/experience preferred
Good understanding of critical processes in R&D in pharmaceutical environment (eg. drug development and approval, clinical trials and investigator-initiated trial processes)
Experience in creating post-approval studies and medical strategies and launch plans
In-depth and up-to-date knowledge of Shire products and competitors’ products
In-depth knowledge of pharmaceutical regulations in key markets
Min. 5 years previous pharmaceutical work experience in Medical Affairs or Clinical Development/R&D Key Skills, Abilities, and Competencies
Good verbal / written communication skills in local language & English
Expert knowledge of applied tools
Excellent skills to discuss and communicate medical and scientific data
Good presentation skills
Ability to organize and structure teams and activities as well as to prioritize and cope with conflicting pressures
Strong team player with good interpersonal and negotiation skills
Awareness of the sensitive and confidential nature of information and situations30% international travel expected
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.