European Development Medical Director - Bone
The European Bone, Neuroscience and Inflammation Therapeutic Area is looking for a European Medical Leader (EML) to serve as a key member of the Romosozumab Global Development Team, working as the single point of contact for Local and Global teams within area of responsibility.
Romosozumab is a key program for Amgen with 2 key Phase III and a suite of other studies currently enrolling in Europe.
This position is located in Uxbridge and will report to the Global Development Leader (GDL) located in Thousand Oaks, California. The ideal candidate will be responsible for leading development of the European Research and Development strategy and activities for the product(s) in accordance with internal and external regulations. The EML will also support the EEMEA region through the existing Therapeutic Area platform leaders. The EML will serve as a important contact for our Alliance partners at UCB for issues and topics pertaining to Europe.
• Works with Global Development Operations to ensure timely and high quality preparation, implementation and completion of Amgen sponsored studies
• Drive execution of clinical studies from a medical perspective
• Identify/resolve issues related to study design that arise during study execution
• Integral to identification of high quality clinical study sites
• Supports regulatory and ethics approvals for Amgen Sponsored Studies
• Leads development of study protocols for European Amgen Sponsored Studies; supports and executes European study protocol preparation, filing, review and approval in line with Amgen processes and policies
• Ensures that European input is included as appropriate in Global Strategic Plans/Global Development Plans and global study protocols and concept documents
• Provides interpretation of clinical study data and preparation/authoring of technical sections of clinical study reports, ensure consistency of CSRs for a clinical program
• Participates in the development of Global strategies and tactics in close collaboration with the Global Development Lead
• Visits selected KOLs and study groups for strategic discussions and protocol development
• Supports regulatory and ethics approvals for Global development studies
• Organizes and/or conducts European Advisory Board Meetings/Expert Panels and participates in Investigator Meetings, as appropriate
• Provides medical expertise for pipeline products
• Provides medical expertise for Health Economy and reimbursement requests
• Responsible for scientific training on Romosozumab in Europe
• Ensures consistency of medical content and scientific messages across various regional tools and materials in alignment with global messaging
• Chairs the European Development Team (EDT)
- For pipeline and peri-launch assets (Phase 2 -> ~Launch + 2 years), the Commercial Strategy Team (CST) will be in place to drive the global Commercial strategy as input to the Product Strategy Team (PST). US Medical Leads & European Medical Leads will provide regional medical input into the CSTs as part of the commercial strategy development process. They will utilize their knowledge of the molecule to help inform the debate around the commercial strategy.
• Medical education or deep scientific expertise in relevant therapeutic area
• MD, specialization in relevant area (ie, Endocrinology, Rheumatology, Orthopaedics, Internal Medicine ) with board certification preferred
• Significant clinical development experience, the majority gained within a pharmaceutical or biotechnology company
• Experience with clinical study management and conduct
• Broad and formal leadership experience
• Clinical research experience with osteoporosis or related programs preferred
Experience in Medical Affairs, ideally in the prelaunch and/or launch phase of a new compound.
• Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
• Therapeutic area knowledge
• Network of customer contacts in therapeutic area