Director, Country Operations Diseases Area Lead

<p><u><b>This is what you will do: </b></u></p><p></p><p>As Director, Country Operations Disease Area Lead (CODAL) you will provide strategic and operational expertise in assigned disease areas to global and country teams to shape optimal strategy and delivery approaches by the site management organization. </p><p></p><p>You will maintain oversight of Alexion Rare Disease portfolio key objectives and achievements for your assigned disease areas and play a key role in supporting the appropriate translation of TA strategy to operational delivery across Alexion Country Operations Management (COM) and AZ Site Management and Monitoring (SMM) functions​. In this capacity, you will serve as the central point of contact for the disease area within the country organization, supporting operational planning, delivery and issue resolution​.</p><p></p><p>As the primary country operations representative for your assigned disease area, you will maintain a connection between the global stakeholders and the country organization to drive consistent delivery of high-quality trials across the full lifecycle of studies (i.e. early planning, feasibility, start-up, conduct, close-out and reporting).</p><p>Collaboration and partnership are key in this position, and a pivotal accountability is to stay updated on internal and external clinical development trends.  You will also be required to engage with partners across the full portfolio at the global, regional and country levels.</p><p></p><p><u><b>You will be responsible for: </b></u></p><p></p><p><b>Feasibility: </b><b> ​</b></p><ul><li>Validating optimal country footprint from initial identification through to finalization (factoring operational viability, expected cycle times, <span>performance/reliability,</span> resource capacity, internal capabilities)​</li><li>Ensuring country organization is equipped with the correct level of information to perform high quality feasibility (i.e. assess what education, data, feasibility insights are required)</li></ul><ul><li>Inputting into the feasibility process, as required</li><li>Engaging internally and externally to drive identification of potential new investigators to expand global footprint, in alignment with TA clinical development plans</li></ul><p></p><p><b>Collecting and sharing lessons learned: </b></p><ul><li>Supporting consistent operational approaches and ongoing process improvement across Alexion clinical studies from COM and SMM (based on Alexion study experience, country cycle time/performance, inspection experience/quality, etc.)</li></ul><p></p><p><b>Input to disease area/indication strategy:  </b></p><ul><li>Representing country organization in global forums to support effective and consistent early planning, feasibility and trial conduct across disease areas</li><li>Supporting with the preparation for governance interactions</li><li>Inputting into therapy area and asset strategy development; analyzing, consolidating, and translating country insights from local stakeholders to actionable process improvements.</li><li>Building and maintaining disease area expertise to provide operational input and impact assessment to study design, documents and plans (e.g. protocol concept sheet, protocol, clinical monitoring plan, site engagement plan, pharmacy manual, etc.)</li><li>Calculating site management resourcing needs (across COM/SMM) for Alexion studies within assigned disease areas</li><li>Embracing digital health, patient/site centricity, and recruitment and retention solutions for studies within assigned disease areas in alignment with global initiatives</li><li>Supporting study prioritization within disease areas</li></ul><p></p><p><b>Identifying risks: </b> <b>​</b></p><ul><li>Maintaining awareness of delivery metrics and related Key Performance Indicators (KPIs) globally across studies to proactively identify risks and recommend timely and consistent implementation of mitigation strategies across assigned disease areas</li></ul><p></p><p><b>Escalation point </b><b>​</b></p><p></p><p>Acting as a primary escalation point for global stakeholders from various departments to facilitate appropriate resolution of COM/SMM issues</p><p></p><p><b>Positioning COM / SMM for success:</b>​</p><ul><li>Providing visibility of the current and upcoming portfolio for assigned disease areas to the site management organization, continuously communicating disease and Clinical Development Plan insights to optimize delivery of short- and longer-term objectives through pipeline reviews with Extended COMLT</li><li>Partnering with COM leadership to formulate country operational delivery strategy</li><li>Providing disease level overviews of key study milestone progress and priority focus areas globally to COM/SMM leadership to drive delivery of high-quality trials across the full portfolio</li><li>Inputting into site management and monitoring strategy (e.g. TSDV, unblinded monitoring requirements)</li></ul><p></p><p><u><b>You will need to have: