Associate Director Strategic Feasibility (12 months secondment/fix term)

AstraZeneca UK

Location: Cambridgeshire, Cheshire East

Job Type: Full time

Posted

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Associate Director Strategic Feasibility role is TA aligned to ensure close partnership with the TA organisations for design and delivery of the portfolio, and to support growing therapeutic knowledge balanced with 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 team, the Associate Director Strategic Feasibility will support data driven strategic design 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 Department, TA leads and CROs to support 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.

Typical Accountabilities

  • Support Director of Strategic Feasibility (DSF) in the development of early study strategy insights, using data intelligence (historical and Real-World Data RWD), and insights from key external and internal stakeholder
  • Support development of site engagement strategy including development of data collection platform such as feasibility questionnaires
  • Lead interaction with local Site management organizations, involved in global feasibility, to convey strategy and collect site data and country commitments
  • Support modelling of strategy options for the study using relevant internal and external data assets, predictive models
  • Support interpretation of data and development of recommendations on operational strategy
  • 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.
  • Supports the implementation of 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 DSF and 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 supports interpretation of 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.
  • Supports planning and delivery of robust strategies for all stages of design feasibility across portfolio
  • Supports planning and delivery of data driven end-to-end operational feasibility in partnership with DSF, to inform site selection 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 meets quality 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. Partners with DSF in presentation and analysis of outputs and contextualizes 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: Site Management & Monitoring Team (SMM) (TA Heads, Regional and Country Leads), TA and Clinical Program Team (Senior /Global Program Directors), Study Physician, and Study Management (SM) Team
  • Supports partnering with Global, Regional and Country TA and Operational Roles to provide early internal pipeline information to enable local markets early evaluation of country participation in programs/studies from strategic and operational perspective.
  • Works in partnership with TA and Clinical Project Teams (CPT), Study Team Operating Model (STOM) roles from SM and SMM, 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 Last Subject In milestone and other patient recruitment objectives
  • Supports study team to manage and resolve globally, operational challenges in 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 drive continued improvement of clinical recruitment efforts adhering to company policies.

Essential

  • 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
  • Experience in managing, influencing, building and maintaining relationships
  • Clinical trial patient and investigator recruitment and retention experience
  • Proven experience working with Global teams
  • Experience in AZ core Therapeutic Areas/Indication
  • Proven experience working in matrix environment with multiple priorities

Needs to demonstrate the following Core Capabilities

  • Data, Analytical, and Technical skills
  • TA knowledge
  • Business Relationship Management
  • Critical and Strategic Thinking
  • Flexibility / Agile Mindset
  • Excellent communication and Influencing
  • Innovation

Technical Capabilities

  • Making decisions and recommendations based on information and data
  • Integrating conflicting views and achieving common goals
  • Excellence in operational planning, strategy and delivery at TA, indication, program level
  • Exploitation and management of information and data

Desirable

  • 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
  • Experience in managing, influencing, building and maintaining relationships
  • Clinical trial patient and investigator recruitment and retention experience
  • Proven experience working with Global teams
  • Experience in AZ core Therapeutic Areas/Indication
  • Proven experience working in matrix environment with multiple priorities
  • MA, MBA in relevant field (e.g. life sciences, business management, project management)
  • New product development experience within the pharmaceutical industry
  • Prior involvement in developing study delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives
  • Proven project/program management or other complex/cross-border management experience
  • Proven experience working with partners, CROs/AROs

Date Posted

20-wrz-2022

Closing Date

07-paź-2022

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.

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