Novartis

Regional Feasibility Lead

1 week agoShanghai, China

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

What you'll bring to the role:
• Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred.
• Fluent English (oral and written)
• ≥ 5 years of pharmaceutical clinical drug development experience recommended (with ≥ 3 years in regional planning/execution of global clinical trials recommended)
• Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and study.
• Possess strong, resourceful research skills to locate unusual information and have capacity to develop a deep domain specific knowledge base. Understand the Clinical Trial matrixed process from research through post marketing phase IV, health authority guidelines, country challenges as well as sources for therapeutic area data

Desirable requirements:
• Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but able to coordinate the activities of others. Demonstrated experience in feasibility for global clinical trials. Demonstrated ability to navigate in matrix environment
• Has demonstrated regional experience in program, project, or trial level budget utilization. Has coached, mentored, on boarded peers and/or new associates. Has had success in identifying, proactively flagging and resolving risks; performed strategic scenario planning and management

Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Division
Global Drug Development

Business Unit
GDO GDD

Location
China

Site
Shanghai

Company / Legal Entity
Novartis Pharma Beijing

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Job ID: Novartis-314325BR