Director Feasibility, SMM CTCO

The Director, Feasibility Cell Therapy is part of the above country structure of Cell Therapy Site Management & Monitoring organisation, supporting the feasibility assessment and delivery of the Cell Therapy Portfolio. The role provides end to end oversight of internally delivered studies within Astrazeneca. This includes two key accountabilities:

1) Feasibility: Strategic input to global teams on operational study design feasibility for early and late-stage medicines development across the Cell Therapy portfolio from study concept through to protocol design, and enrollment planning from initial concept through to study baseline/re-baseline following allocation. The Director delivers actionable Site Management and Monitoring (SM&M) operational feasibility insights to enable optimal study design and right country/site allocation.

2) Oversight of SM&M Delivery at Portfolio level: They ensure the effective oversight and early risk detection of key SM&M portfolio milestones across Cell Therapy Clinical Operations (CTCO) countries engaging SMM global leadership team. They drive SMM portfolio alignment and collate and interpret oversights within SMM and engage with global teams to support global operational delivery strategy.

The role requires experience and knowledge in developing Global Feasibility Strategies, balanced with global project management capabilities, strategic thinking, data analytics/interpretation and technical skills as well as a good understanding of global footprint priorities.

Partnering with CTCO Sr DSMM Feasibility, the region Associate Directors Feasibility, SMM country teams, and key stakeholders within CTCO (Site Partnerships, Program Management & Patient Operations) and wider Cell Therapy R&D teams, to support predictable delivery, ensuring standardization in use of data, tools and process to inform quality decision making.

The role sits within CTCO SMM within the Feasibility Team. The TA lead is also an extended LT member of the SM&M team.

The TA lead represents SM&M in various cross functional optimisation and engagement workstreams, including to drive and rollout projects.

Feasibility

• Responsible for establishing and implementing global SM&M Therapeutic Area (TA) feasibility and country footprint strategies for studies they are leading on.
• Responsible for the delivery of high-quality study level feasibility assessments by the collation and critical assessment of external input and internal intelligence from CTCO SM&M, providing actionable insights to project teams, ahead of governance (i.e. ESPC/LSPC etc).
• Utilize market insights and data strategy combined with TA expertise to define optimal countries and sites for feasibility participation, ensuring endorsement from SM&M leadership for country and site footprint.
• Ensures robust global SM&M insights to support strategic indication landscape, study design assessment, and protocol/site feasibility.
• Identifies and evolves the optimal feasibility processes, training and systems, and administers governance of systems and sources.
• Responsible for driving standardization within SMM in conduct of feasibility, site selection, operational projections and processes. Championing sharing of best practice across SMM countries, via Associate Directors Regional Feasibility, Local Feasibility Leads and SMM portfolio meetings.
• Line manager to and oversight of Local Feasibility Lead (LFL) within Cell Therapy markets globally, ensuring consistency of global strategy at country level.
• Experts in data sources and tools to provide data insights into feasibility strategies. Optimises existing feasibility data sources and tools and looks to identify partnership externally to bring the best technology into the process.

Oversight of SM&M Delivery at Portfolio level

• Responsible for SM&M early risk detection across TA for new and ongoing studies to ensure SM&M performance to business-critical milestones and KPIs (e.g. recruitment completion and predictability, study cycle time reduction) across countries and at global level. Support build and subsequent oversight and maintenance of feasibility trackers and databases. Ensures corrective actions are implemented within SM&M.
• Maintains high level of awareness on new strategic portfolio management/development trends internally and externally at global level and translates these into the SM&M organisation. Interfaces with global teams to share input on market level insights into TA strategy.
• Contributes to SMM portfolio meetings, including driving agenda.
• Working closely with Program Teams, Associate Directors Regional Feasibility to review the indication landscaping and future portfolio to prepare SM&M for delivery.

Other areas

• Identifies opportunities for innovation and process improvement for Feasibility SM&M, leads scope definition of respective projects and endorsement by SM&M leadership.
• Represents SM&M in Global Optimisation workstreams.
• Provides direction to Associate Directors Feasibility team.
• Secure traceability of assumptions and transparency in decisions for end-to-end process
• 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.
• The job holder requires a high level of cultural sensitivity, interactive communication, negotiation and effective collaboration.

The annual base salary (or hourly rate of compensation) for this position ranges from $171,622.40 - $257,433.60. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Are you ready to bring new insights and fresh thinking to the table?Fantastic! We have one seat available, and we hope it’s yours. Apply today.

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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Date Posted

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