At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.
Our purpose is bold and so is our approach. Becoming a more agile and innovative company means creating a vibrant, dynamic culture where we celebrate entrepreneurial thinking and motivated by a sense of urgency. We are courageous, we seek risks and learn from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver needed medicines.
Position Title: Feasibility and Recruitment Partner
Position Type: Regular, Full-Time
Location: The successful candidate will work/reside in Gaithersburg, Mississauga, Cambridge, Gothenburg, Warsaw
Career Level: F
The Feasibility and Recruitment Partner role is TA aligned to ensure close partnership with the TA organisations for design and delivery of the portfolio, and to ensure in depth therapeutic knowledge balanced with strong data analytics/interpretation and technical skills. And a good understanding of global, regional and local country landscape and priorities.
Aligned within Global Feasibility and Site Intelligence function, the Feasibility and Recruitment Partner will play a critical role in data driven strategic and operational feasibility, site identification, and recruitment and retention recommendations for early to late stage medicines development across Oncology and BioPharmaceuticals R&D, beginning at the concept stage through to execution.
Partnering with key stakeholders within Development Operations, TA leads and CROs to enable expedited, predictive delivery for all stages of global feasibility, ensuring standardization in use of data, tools and process to inform quality decision making at TA, indication, program and study levels.
Your responsibilities will include:
- Provides data driven strategic design and operational feasibility, including site identification, and recruitment and retention recommendations at TA/indication/program level taking into consideration unique needs of indication, patient population, study and business priorities.
- Proactively leads standardized design feasibility offering, leveraging data intelligence (historical and Real-World Data RWD), and insights from key external and internal experts to support study teams from program concept to protocol design and study set-up
- Partners with study design teams enabling data-driven approaches to inform decision making and improve predictability of execution
- Leverages relevant internal and external data assets, advanced analytical models, and interprets data to provide recommendations to study teams in a meaningful way to support planning.
- Links study team to other internal groups for patients and site insights and data to inform design and planning
- Proactively identifies new opportunities for data utilization to optimize study delivery.
- Plans and delivers robust strategies for all stages of design feasibility across portfolio
- Plans, manages, and delivers data driven end-to-end operational feasibility, to inform site selection and and baseline recruitment forecasts and study milestones
- Leverages relevant internal and external data to inform recommendation on site ID, and manages validation of data by incorporating TA expertise and operational perspectives to ensure data is reflective of reality and meetsquality standards
- Optimizes predictive models to inform enrolment probability of success for various strategic and operational scenarios
- Enables operational excellence by driving scenario modelling that meets study design constraints and business operational efficiency targets Presents analysis outputs and contextualize results for study and operations teams to ensure balanced decision making
- Leverages predictive models to inform baseline activation and recruitment forecast and key study milestones for study planning
- Transfer knowledge, expert advice and best practice globally, across TA, program
- Ensure consistency in use of data driven tools and analytical models across portfolio
- Secure traceability of assumptions and transparency in decisions for end-to-end process
- Expert user for new study design and planning digital platform (Merlin) and optimization models. Provides continuous enhancements of tool features to meet needs of current practice. Explores new data assets to predict parameters for feasibility and formulate recommendations
- Engages key roles in business involved in feasibility and site selection: Study Management and Monitoring region and country roles, TA and Clinical Project Team roles (e.g. Director of Clinical Development/Associate Director of Clinical Development, physician leads), global study team
- Acts as advisor for external CRO/ARO delivery for all stages of feasibility from early program design to study execution.
- Partners with Regional and Country operational roles to provide early internal pipeline information to key roles at regional level (BSPD) to enable early evaluation of country participation in programs/studies from strategic and operational perspective.
Works in partnership with TA and Clinical Project Teams (CPT) (e.g., Director, Clinical Development (DCD), physicians leads), Study Team Operating Model (STOM) roles (Global Study Leader, Site Management and Monitoring (SMM) Lead, as main stakeholders, to plan, develop and achieve recruitment and retention goals via strategic intelligence and data-driven early planning. - Partners with internal and external experts for implementation of effective patient and site centred tactics and strategies, emerging technologies and innovative practices to drive digital engagement and patient centricity in the design and execution of clinical trials.
- SME in the identification of and analysis of key strategic intelligence, country and site strategy with risk and mitigation, contingency planning, development of scenarios determining start up and recruitment focusing on increasing predictability in early portfolio and study planning.
- Supports Study Teams to manage global implementation strategies to deliver planned global LSI milestone and other patient recruitment objectives
- Supports SMM Lead to manage and resolve globally escalations by TA and CPT roles and applicable SMO roles and other customers with regards to SMM delivery of patient recruitment commitments
- Delivers global patient recruitment KPIs and other performance dashboards for Development Operations. Contribute to innovation projects and continuous process improvement within Clinical
- Maintains awareness of marketplace activities, policies, trends, technology, new data sources and information affecting the business and organization to support continued improvement of clinical recruitment efforts adhering to company policies.
Your qualifications and experiences include:
- Bachelors degree in relevant field (e.g. life sciences, business management, project management)
- Experience from Drug Development and Feasibility in the pharmaceutical industry
- Proven experience in data analysis, data interpretation to drive inform decision making
- Proven experience in managing, influencing, building and maintaining relationships and achieving results with senior stakeholders in conflicting priority environment
- Proven experience in developing study delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives
- Clinical trial patient and investigator recruitment and retention experience
- Proven experience in project and budget management
- Proven experience working with Global teams
- Experience in AZ core Therapeutic Areas/Indication
Your may have the following qualifications or experiences:
- MA, MBA in relevant field (e.g. life sciences, business management, project management)
- New product development experience within the pharmaceutical industry
- Proven project/program management or other complex/cross-border management experience
- Proven experience working with partners, CROs/AROs
- Proven experience in the development of business cases
Date Posted
16-Dec-2019Closing Date
13-Jan-2020AstraZeneca 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.
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