Shire Head GMA Immunology in Zug, Switzerland
Leads and develops the Immunology Therapeutic Area (TA) Global Medical Affairs (GMA) team. Defines Immunology medical strategy, appropriately aligned with overall TA strategy and incorporates R&D functional strategies (clinical, regulatory, HEOR, PV, compliance). Responsible for multi-year Immunology medical performance and strategy. Member of Immunology and GMA Leadership Teams. Serves as the GMA and R&D lead on the TA leadership team and coordinates ongoing R&D activities for Immunology inline products in conjunction with clinical research/development, regulatory, HEOR and pharmacovigilance as appropriate. Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities. Assists with assessments and intelligence on potential new products relevant to Immunology therapeutic areas and assists with due diligence activities. Establishes and tracks appropriate performance metrics at the Immunology and product/disease levels. Maintains a level of expertise through familiarity with clinical practice, treatment standards and medical and scientific literature within therapeutic areas of interest to the Immunology.
• Definition of Medical and in-line R&D strategy. Participates in GMA Leadership Team definition of GMA strategy. Participates in TA Leadership Team definition of TA strategy. Leads TA R&D in-line team and define in-line R&D strategy. Leads TA Medical team and oversee development of TA medical plans. Contributes to assessments of potential new products in BU therapeutic areas. (20%)
• Implementation of strategy and management of Immunology MA budget and resources. Oversees implementation of TA Global Medical strategies and plans. Defines and oversees implementation of overall TA GMA budget. Defines TA GMA requirements from SMS (Publications support, Medical Communications support, Medical Information support, Systems and Operations Support). Defines and implements TA GMA requirements in the US. Defines TA GMA requirements. (35%)
• Mentoring, training and performance management. Identifies and addresses training and development needs for Immunology GMA team, including Immunology-related needs of SMS teams. Mentors and supports team members managing other team members. Performs routine performance and talent reviews. Establishes and tracks appropriate performance metrics at the TA and product/disease levels. Provides motivational leadership and actively motivates, encourages and rewards individuals for their commitment and ongoing efforts to achieve company goals. (20%)
• Establishment and maintenance of a compliant environment. Coordinates with Legal, Compliance, PV and Regulatory to ensure appropriate systems, processes and training is in place in BU GMA. (10%)
• Interaction with external stakeholders. Oversees definition of TA KOL plan. Establishes and maintains strategic partnerships with Key Opinion Leaders in all therapeutic areas. Interacts with patient advocacy, policy and regulatory bodies as a senior representative of Shire and a medical expert within therapeutic areas. Represents GMA at internal and external meetings. (10%)
• Maintenance of Immunology disease area knowledge base. Represents company’s interest in scientific forums as needed. (5%)
Education & Experience
Essential: MD degree and at least ten years of experience in biopharmaceutical medicine; experience in medical affairs; experience in designing and conducting registration or phase IV studies; Experience leading teams at the brand or disease area levels in country, regional or global organizations.
Desired: Experience within a matrix structure; experience leading field teams; experience in specific TA therapeutic areas through clinical experience or biopharmaceutical industry experience.
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.