Regional Feasibility Lead

Mar 11, 2021

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Your key responsibilities:
·Accountable for program and trial level feasibility within assigned region.Leads regional feasibility with Country Organizations (COs) to develop regional feasibility and allocation strategy scenarios. Reviews and provides regional level insights on analysis of clinical intelligence data describing the indication landscape, scientific and epidemiology data, competitive intelligence, treatment paradigms and potential site partners globally. Partners with Global (Associate) Director Strategic Planning and Feasibility to utilize external and internal research data sources, based on the clinical intelligence package received from Health Insights Director.
·Accountable and responsible for providing regional feasibility, allocation and site selection strategies of assigned program(s) and/or trial(s), including timelines and scenarios in alignment. Flags and describes events in the indication landscape that represent regional operational risks for the execution of the clinical trials within the given indication. Leads integration of local indication strategies within regional execution plans. Develops risk management strategies for assigned region, including operational risks for regional feasibility and allocation.
·Drives regional feasibilities in the COs and communicates aggregated feedback to the Global (Associate) Director Strategic Planning and Feasibility; Supports integrated development plan, concept sheet, protocol development and/or trial design based on the regional feasibility feedback collected; ensures feedback given during feasibility process is answered and provided to COs.
·Leads regional allocation process to ensure adequate patient accessibility and alignment with country strategies, including re-allocation or corrective action when needed. Collaborates closely with Global (Associate) Director Strategic Planning and Feasibility and Regional Head, Portfolio Delivery Office to ensure alignment of feasibility & allocation strategy and seamless start up planning.
·Performs ongoing analysis and reassessment of regional feasibility against recruitment throughout the lifecycle of the trial. Ensures alignment of feasibility and allocation strategy and seamless start up planning with Global (Associate) Director Strategic Planning and Feasibility, in collaboration with Regional Head, Portfolio Delivery Office, Country Heads, Monitoring Excellence groups.
·Partnering with Global Health Insights Managers, build center of excellence in strategic feasibility and allocation planning within assigned Region by developing process standards and tools to achieve strategic regional feasibility and allocation excellence in GDO. Participates and/or leads multidisciplinary taskforces to support continuous improvement and other management initiatives.
·Participates in the development of innovative solutions in regional planning and feasibility, to ensure the delivery of assigned programs and/or studies on time. Contributes to continuous improvement of the tools used within the Feasibility Management organization.Key contributor and lead for Feasibility Management forums, initiatives, or working groups. Serves as faculty member for franchise training programs.
·As the regional feasibility expert, interacts with external stakeholders (e.g., key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., NIBR, Commercial, Global Medical Affairs (GMA), Marketing), and internal decision boards

Minimum Requirements

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Global Drug Development
Research & Development
Full Time

Regional Feasibility Lead

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