Director, Ta Lead Feasibility And Portfolio Delivery, Sm&M

hace 3 semanas

Barcelona, España Astrazeneca Gmbh A tiempo completo

Location: Barcelona (on-site) The Director, TA Lead Feasibility and Portfolio Delivery (TA Lead) provides SM&M end to end oversight of internally delivered studies within Astrazeneca for a defined Therapeutic Area (TA). This includes two key accountabilities:
1) Feasibility: Strategic Therapeutic Area (TA) input to global teams on operational study design feasibility from study concept through to protocol design. The TA lead delivers actionable SM&M operational feasibility insights to enable optimal study design and right country/site allocation.
2) SM&M Portfolio Oversight: They ensure the effective oversight and early risk detection of key Site Management and Monitoring (SM&M) portfolio achievements across Oncology SM&M countries engaging Oncology SMM global leadership team and Country Heads. They drive SMM portfolio alignment for their TA and collate and interpret oversights within SMM and engage with global teams to support global TA operational delivery strategy.
They are play a key role in ensuring that SM&M insights into global TA strategy and supporting the delivery of the portfolio in the countries across geographies.
The Therapeutic Area this role will be accountable for is Early Oncology. This will include dose critical issue studies, through to dose expansion (Phase I to II).
The role sits within Oncology Site Management and Monitoring within the Feasibility and Portfolio Delivery Team. The TA lead is also an extended LT member of the Oncology SM&M team.
The TA lead represents SM&M in various cross functional optimisation and engagement workstreams.
Typical Accountabilities Feasibility Responsible for establishing and implementing global SM&M Therapeutic Area (TA) feasibility and country footprint strategies for their TA.Leads and delivers high quality study level feasibility assessments by the collation and critical assessment of external input and internal intelligence from Oncology SM&M, providing actionable insights to project teams.Apply 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 and systems.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 SMM leads and SMM portfolio meetings.Oversees and supports Local Feasibility Lead networks within 25 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. Portfolio Delivery and Oversight 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, database lock, study cycle time reduction) across countries and at global level. Ensures risks are identified early and corrective actions are implemented within SM&M. Working closely with Program Teams, reviews the indication landscaping and future portfolio to prepare Oncology SM&M for future portfolio.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. Collaborate with global teams to share input on market level insights into TA strategy. Leads SMM portfolio meetings for the TA providing portfolio insights and leading within SM&M and with the global team. Supports and coordinates TA aligned SM&M leads across all AZ countries.Provides full visibility of their SM&M portfolio of work to shape and influence decisions through Executive Hub Heads and Country Heads to optimize delivery within SM&M for short and longer term.Delivers SMM Innovation through adoption of new technology and processesOther areas Represents SM&M in Global Optimisation workstreams.Provides direction to Associate Directors and Analysts within the Feasibility and Portfolio Delivery team. May also include line management of these roles.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.Education, Qualifications, Skills and Experience Essential Bachelor's Science degree in an appropriate subject area, preferably in medical or biological sciences.Substantial experience in Pharmaceutical Industry in Clinical Development and Study OperationsProven critical thinking, experience of strategic project/portfolio management within a clinical or pharmaceutical environmentProven experience of clinical development / drug development process in various phases and therapy areas and working in a global environmentGood understanding and keen interest in digital solutions and technologyProven leadership ability promoting, motivating and empowering others to accomplish individual, team and organizational objectivesAwareness and sensitivity to cultural diversityExcellent problem solving and conflict resolution skillsAbility to look for and champion more efficient and effective methods/processes of delivering clinical trials to plan focusing on key performance metrics of speed, quality, cost Strong orientation towards external environment and internal partnersManages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and contribute to the businessDedicated team playerIntegrity and high ethical standardsExcellent written and verbal communication skills (English), negotiation, collaboration and interpersonal skillsDesirable Early Oncology Experience in the Feasibility Setting.Professional qualification – Mastery of Clinical Development area and multi-disciplinary experience (cross-functional or functional)Experience of Feasibility in the pharmaceutical industry.Ability to influence strategically and persuade tactfully, to obtain desired outcomes while maintaining effective, positive, organizational relationshipsExtensive knowledge of the latest technical and regulatory expectationsFamiliarity with the latest research and thinkingExcellent knowledge of AstraZeneca policies, procedures and guidelines
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