Director, Global Study Planning   

Hybrid Work- on average 3 days/week from office

Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The Director, Global Study Planning will be accountable for delivering the global study start-up strategy for new programs and studies including but not limited to indication landscaping, feasibility, data insights collection, data analysis, and early operational strategic planning.

Working closely with the program and study teams, the role will coordinate and support data-driven start-up planning, operational feasibility assessment, country and site identification, and assist in recruitment and retention recommendations for early to late-stage medicines development from a global perspective. Through close partnerships across organizations and functions, the role will ensure effective, predictive delivery for all stages of global study feasibility, standardize processes, and optimize the use of data and tools to inform quality decision-making.

This role will support growing therapeutic knowledge within the rare and ultra-rare disease area balanced with data analytics/interpretation and technical skills with a good understanding of global, regional, local country landscape, program priorities, and the needs of sites and patients.

Responsibilities:

• Partner with key stakeholders including: Clinical Operations TA Head, Global Program Directors (GPD) Study Managers (Global Study Associate Director (GSAD)/Global Study Manager (GSM)), Country Operations Disease Area Lead (CODAL), Global Program Team Lead (GPTL), Epidemiology, ESE (External Scientific Engagement), Patient Experience (Global Patient Recruitment and Engagement (GPR&E) and Global Patient Advocacy), to develop study plans for achieving recruitment and retention goals via strategic intelligence and data-driven early planning.
• Drive and coordinate in partnership with Development Operations TAs, the end-to-end global study planning activities including indication landscaping and study feasibility, insights generation (Site Friction Coefficient, patient journey), development of data collection surveys such as feasibility questionnaires, and collate relevant information from cross-functional partners to support informed decision making.
• Leverage relevant internal and external data assets, existing tools and analytical models, novel approaches and sources of data to develop strategic scenarios focusing on increasing predictability in early portfolio and study planning.
• Contribute to interpretation of data and provide recommendations to study teams to support development of strategic design and operational feasibility, including country and site selection, and recruitment with risk and mitigation, timelines, contingency planning, and retention recommendations at TA/indication/program level taking into consideration unique needs of indication, patient population, study, and business priorities.
• Present and analyze feasibility assessment outputs contextualizing results for study and operations teams to ensure balanced decision making as required.
• Optimize predictive models to inform enrollment probability of success for various strategic and operational scenarios.
• Identify present and future changes that pose risks to delivery models (e.g., competition, changes in patient management).
• Ensure consistency in use of data-driven tools and analytical models across the portfolio.
• Proactively maintain awareness of new data utilization opportunities and technical innovations to optimize global study planning and delivery.
• Contribute to continuous enhancements of tool features to enhance the needs of current practice and explore new data assets to predict parameters for feasibility and formulate recommendations.

Essential Skills/Experience:

• 10+ years experience in clinical operations with extensive experience in study start-up activities including indication landscaping, feasibility, and execution of study planning strategy.
• Effective Collaboration - Team player with the ability to coordinate and influence cross-functional stakeholders without authority.
• Strong communication skills - Ability to present complex data and analysis to stakeholders to support and influence decision making.
• Strategic planning – Experience in developing study delivery strategies and tactical/operational plans.
• Good Analytical skills – Proven experience in the analysis and interpretation of data from different sources to formulate recommendations that inform decision making.
• Growth mindset – Ability to adapt to changing environment and organizational needs, experience with piloting or implementing new technology, systems, & tools (including AI, digital outreach, etc.). Innovative & open to taking smart risks.
• Bachelor’s level degree or higher education required.

Desirable Skills/Experience:

• Advanced degree (MSc., MBA) is highly desirable.
• PMP certification desirable.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

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.