Director, Country Operations Disease Area Lead (Alexion)

Director, Country Operations Disease Area Lead

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. 

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​.

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).

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.

You will be responsible for:

Feasibility:  ​

• Validating optimal country footprint from initial identification through to finalization (factoring operational viability, expected cycle times, performance/reliability, resource capacity, internal capabilities)​
• 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)

• Inputting into the feasibility process, as required
• Engaging internally and externally to drive identification of potential new investigators to expand global footprint, in alignment with TA clinical development plans

Collecting and sharing lessons learned: 

• 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.)

Input to disease area/indication strategy: 

• Representing country organization in global forums to support effective and consistent early planning, feasibility and trial conduct across disease areas
• Supporting with the preparation for governance interactions
• Inputting into therapy area and asset strategy development; analyzing, consolidating, and translating country insights from local stakeholders to actionable process improvements.
• 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.)
• Calculating site management resourcing needs (across COM/SMM) for Alexion studies within assigned disease areas
• Embracing digital health, patient/site centricity, and recruitment and retention solutions for studies within assigned disease areas in alignment with global initiatives
• Supporting study prioritization within disease areas

Identifying risks: ​

• 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

Escalation point ​

Acting as a primary escalation point for global stakeholders from various departments to facilitate appropriate resolution of COM/SMM issues

Positioning COM / SMM for success:​

• 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
• Partnering with COM leadership to formulate country operational delivery strategy
• 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
• Inputting into site management and monitoring strategy (e.g. TSDV, unblinded monitoring requirements)

You will need to have:

• BSc in a relevant field with substantial experience in Pharmaceutical Industry, particularly in Clinical Development and Study Operations. This is complemented by a strategic approach and experience in strategic project management within a clinical or pharmaceutical environment.
• To be successful in this role, you need to have excellent interpersonal skills and the ability to analyze external trends to influence internal partners. You have a high level of cultural sensitivity and interactive communication, which fosters effective cross functional and global collaborations. Furthermore, you are a dedicated team player, adept at managing change with a positive approach for self, team and the business.
• Proven experience of clinical development and drug development process in various phases and therapy areas, and working in a global environment
• Good understanding and keen interest in digital solution and technology
• Proven leadership ability promoting, motivating and empowering others to accomplish individual, team and organizational objectives
• Excellent problem solving and conflict resolution skills
• Actively seek and champion more efficient and effective methods and processes for delivering clinical trials to plan, with a keen focus on key performance metrics of speed, quality and cost

We would prefer for you to have:

• Masters or PhD in scientific subject area
• Professional qualification – Mastery of Clinical Development area and multi-disciplinary experience (cross-functional or functional)
• Ability to influence strategically and persuade tactfully, to obtain desired outcomes while maintaining effective, positive, organizational relationships
• Extensive knowledge of the latest technical and regulatory expectations
• Familiarity with the latest research and thinking
• Excellent knowledge of Alexion and AstraZeneca policies, procedures and guidelines

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.