Director Feasibility, SMM CTCO

AstraZeneca

7d • $171,622 - $257,434

About The Position

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.

Requirements

• Experience and knowledge in developing Global Feasibility Strategies
• Global project management capabilities
• Strategic thinking
• Data analytics/interpretation and technical skills
• Good understanding of global footprint priorities
• High level of cultural sensitivity
• Interactive communication
• Negotiation and effective collaboration

Responsibilities

• 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.
• 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.
• 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.

Benefits

• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed