BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Regional Program Lead is accountable at the regional level for the strategic planning and delivery of assigned clinical programs within timelines, budget and appropriate quality.
The regional Program Lead ensures:
1. oversight of the portfolio in scope, proactively anticipating risks and mitigation strategies for the region and program
2. alignment of regional resources and deliverables with overall global portfolio goals in assigned clinical program.
The Regional Program Lead is the regional representative at Global Program Level and Governance boards.
The Regional Program Lead line manages a group of regional Clinical Study Managers who manage trials day to day and provides leadership, management, and/or mentorship to Regional Clinical Study Managers for assigned portfolio. He also contributes to resourcing and capability development related to regional study management.
Essential Functions of the job:
3. Defines operational strategy for assigned clinical programs and translates it into concrete steps for operational implementation.
4. Builds long term indication level operational plans, in collaboration with regional and country stakeholders.
5. Drives Program strategy and indication knowledge in team and adapts operations accordingly.
6. Ensures that knowledge of the global marketplace and competitors is used within assigned program to create operational competitive strategies and plans and defines objectives around emerging patient needs.
7. Ensures consolidation, oversight, and forecast of key trial conduct milestones.
8. Liaises with other program Regional Program Leads and Regional Feasibility Leads during feasibility for overlapping or synergistic indications/populations across programs.
9. Provides leadership to the Regional Clinical Study Managers for the delivery of one or several clinical trials in the region, within timelines, budget and appropriate inspection readiness quality.
10. Is responsible for the country selection on the studies of their program in collaboration with the Regional Clinical Study Manager and based on feasibility conducted by country teams and the Regional Strategic Feasibility Lead
11. Is the counterpart of the Global Clinical Program Lead at the regional level.
12. Represents the region in discussions at Global Program Level and Governance boards (GCPL, DCT, GPT, bi-weekly business review meetings).
13. Responsible for the interactions with regional program level stakeholders (e.g. Medical Affairs, Regulatory).
14. Interacts with regional GCP Compliance as appropriate.
15. Leads program level relationship with patient advocacy groups.
16. Conducts regular program review meetings, as part of the oversight of regional Clinical Study Managers and study deliveries.
17. Provides expert knowledge on the execution of clinical trials through deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements.
Supervisory Responsibilities:
Line management responsibilities:
18. Conducts performance appraisals for direct reports which includes providing feedback.
19. Supports set up of development plans for direct reports.
20. Contributes to the hiring of new talent into the regional study management organization.
Education Required:
21. Bachelor's degree in a scientific or healthcare discipline and 10+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.
22. Preferably master’s degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.
Computer Skills: MS Office, Project Planning Applications
Other Qualifications: Extensive experience in clinical study/program management at regional or global level.
Travel: Travel might be required as per business need.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
23. Fosters Teamwork
24. Provides and Solicits Honest and Actionable Feedback
25. Self-Awareness
26. Acts Inclusively
27. Demonstrates Initiative
28. Entrepreneurial Mindset
29. Continuous Learning
30. Embraces Change
31. Results-Oriented
32. Analytical Thinking/Data Analysis
33. Financial Excellence
34. Communicates with Clarity