Shire Head of Continuum of Access to Medicines (GMA) in Zug, Switzerland
▪ Establish a patient-focused global framework for Continuum of Access to Medicines for Shire
▪ Provide strategic leadership to the CAM group
▪ Oversee the implementation of the Shire CAM governance model in all regions
▪ Establish relationships with key external parties (e.g. NGOs, payors, regulators, patient advocacy groups) at senior leadership levels
▪ Act as a senior policy advisor to Shire on issues related to CAM and its components (Post Trial Access, Named Patient Access, Post approval interim access, Charitable Access, Compassionate Use)
▪ Provide central strategic leadership and oversight of medical affairs CAM programs including charitable, named patient access(NPA), compassionate use and post-trial access as well as oversight of the operational execution of these programs, globally in close collaboration with clinical development and clinical operations
▪ Represent GMA-CAM as a senior GMA Leader at executive bodies within Shire, such as In-line committee, Pipeline Committee, International commercial Leadership Team, etc.
▪ Leads development and execution of multi-year global CAM strategy for the specified pipeline asset/Product/Disease Area,
▪ Serves as the chair of the multifunctional CAM governance committee.
▪ Development and management of the Global Medical CAM budget
▪ Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities, Non-Government Organizations (NGOs) and Government Health Care Authorities
▪ Establishes appropriate strategic partnerships with external stakeholders incl. patient advocacy groups, NGOs, centers of excellence and KOLs in areas of CAM interest
▪ Collaborates with Legal, Compliance and Regulatory to ensure proper and ethical interactions between GMA (CAM) personnel and external stakeholders
▪ Navigates a politically sensitive area and ensures maintenance of Shire’s reputation in this area.
Oversee development of global medical CAM strategy and plans in close collaboration with respective TAs
Lead development of medical CAM strategy including external partner selection (ie. NGO partner) and engagement, external stakeholder interaction strategy, and support the CAM communication platform development for the TA / brand(s), pipeline assets, aligned with product strategy
Develop in-year medical CAM tactical plan and budget for the global programs/projects
Support functionally the development of pipeline asset/Product/Disease Area CAM plans aligned and in support of overall global medical CAM strategy and established best practices
Leads the collaboration with clinical, commercial, access, corporate philanthropy to ensure aligned and medically appropriate CAM strategy, planning and execution.
Participate in development of product strategy; provide CAM medical affairs inputs for product(s) to LPTs
Define Global GMA CAM team goals and key performance metrics
Lead and Develop the Global Medical CAM Team
Collaborate with Legal, Compliance and Regulatory and Medical Training to ensure understanding and adherence of global medical CAM team to Shire and external policies and regulations
Coordinate with TA Heads of Medical Affairs, US and International Medical Affairs, Global Medical Teams and Global Medical Training to define and address global medical team CAM training and professional development needs and CAM training needs related to the CAM
Mentor and develop global medical CAM team
Monitor CAM team performance in terms of goals and delivery of medical CAM plans and identify areas for development
Oversee and manage in-year implementation of global medical CAM strategy
Directly lead global and guide (US & International) implementation of CAM strategy, potentially including:
Providing leadership for medical CAM communications, including standard responses and publications
Monitor and communicate progress against medical CAM plan; propose and initiate initiatives as need to adjust to disease area requirements
Overseeing CAM review and approval of meeting materials
Interaction with senior external stakeholders in alignment with customer needs and medical CAM strategy
Act as a senior company representative with external scientific leaders, policy makers, patient advocacy groups, NGOs and/or regulatory / government authorities
Establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders
Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities, NGOs and industry trade groups
Represent CAM Medical Affairs at internal and external meetings
Maintenance of knowledge base
Serve as a key medical resource on Shire CAM processes, best practices and implementation
Maintain a high level of expertise on CAM policies and external developments
Develop and maintain knowledge of global pharmaceutical regulations, guidelines, codes of practices and Shire policies related to all medical CAM activities
Develop, conduct, or participate in therapeutic CAM training programs for Shire internal departments
Advanced degree in a relevant health care field is required (PharmD, PhD, MD). A medical degree is preferred
15+ years of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure.
Experience at a senior leadership level in medical affairs is required
Experience leading teams at the brand or disease area levels in country, regional or global organizations is required
Experience in field-based roles (e.g. Medical Director, Medical Science Liaison) is preferred
Experience in humanitarian programs is preferred
Experience in clinical development is preferred
Experience in the disease area of interest through clinical experience, biopharmaceutical experience or education is preferred
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.