Accountable for overseeing the strategic plan and supporting innovative projects for the Trial Management function. Accountable for implementing novel trial technology oppor-tunities and objectives for Trial Management as well as contributing to ideating, establish-ing and driving advanced data-driven methodologies, process re-engineering improve-ments to substantially enhance the delivery of clinical trials. Accountable for establishing innovation hub within Trial Management and leveraging business SMEs, as well as as-signment of Initiatives Leads / Trial Management contributors to GDO owned Operational Excellence Initiatives (Tier 1 & Must Dos). Lead cross functional initiative teams by setting strategy, ensuring appropriate cross functional resources and delivery of goals.
Support the implementation of Trials of the Future , by coaching and establishing the cross functional teams driving, piloting and evaluating advanced data-driven method-ologies and practices to enhance clinical trial delivery to become an industry leader.
Drive successful execution of key innovative strategic projects within Trial Manage-ment in line with short-, medium- and long-term strategies; Translate new strategy in-to concrete objectives, with conversion into cross functional iCTT initiatives / pilot pro-grams related to new digitalization.
Support the Trial Management evaluation of all new innovative / data driven digital vendors and tool providers for analysis and recommendations of use, in line with sup-port of External Development Operations.
Track and review progress of all initiatives and projects in Trial Management and en-sure they embed and support strategic imperatives as required. Utilize available re-sources within PTO (Process Technology Optimization) PMO group as needed.
Collaborate with Global Drug Development Quality / Quality Management System for alignment on Standard Operating Principles and Procedures (deviations as applicable) to allow full capacity testing of innovative vendor / data driven processes for pilot iCTT teams.
Establish strong partnership with GDD Quality QMS for alignment on integration of technology opportunities within Trial Management.
Support implementation of bottom up platform that enables idea generation/ solu-tions across Trial Management End users to drive transparent strategy of open en-gagement to the organization to ensure adoption of change that drives cohesive con-tinuous improvement.
Evaluate external innovation landscape for the benefit of GDO and Trial Management; Explore and evaluate innovative solutions to improve trial management in support of global development goals.
Lead/co-lead creation and deployment of data-driven innovations to business model that result in step-change in trial management processes and practices with signifi-cant enhancements to efficiency and productivity.
Serve as a Trial Management champion for cross-functional initiatives and innovations that involve Trial Management (e.g. Harmonized Protocol Development Timelines, End-to-End-Mapping, Pain Point Collation) to ensure alignment with future innovative / digitalization strategy.
Champion adoption of integrated innovative solutions by A/GTDs and support iCTT implementation and cross pollination across development unit and program teams.
Ensure awareness of trends in the industry in the field of innovation in trial manage-ment by scanning external & internal operational trends and evaluating new innova-tive technologies and practices to continuously evolve.
Represent innovation in any Trial Management Forums, development wide initiatives and meetings in relation to Innovation and Strategy.
Act as deputy on behalf of Global Head, Strategy & Innovation for select meetings and provide updates at Operational Excellence and DCN meetings as required.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor s Degree required, preferred in Life Sciences ; Advanced Degree in science or business preferred
1. At least 10 years of experience in pharmaceutical development, preferably in global strategy, innovations or clinical operations role
2. Thorough understanding of process control techniques such as Statistical Process Control (SPC), Six Sigma, Lean Sigma. Six Sigma Black Belt certification preferred.
3. Demonstrated leadership in innovation of pharmaceutical development processes and in technical approaches
4. Demonstrated leadership in leading cross-functional teams and has high level of Project management expertise.
5. Demonstrated quantitative skills along with demonstrated application of quantitative approaches to re-designing processes, improving productivity and/or improving efficiency
6. Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations
7. High level of organizational awareness, including significant experience working cross-functionally and in global teams
8. Superior strategic thinking skills
9. Demonstrated matrix management skills and ability to influence in project team setting
10. Excellent communicator and presenter (verbal and written), ability to communicate to Sr. Leaders
11. High level of competence and skill with various IT systems including SharePoint and web-based collaboration / innovation platforms
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