BeOne Medicines I GmbH is seeking an Associate Director, Regional Program Lead to be accountable at the regional level for the strategic planning and delivery of assigned clinical programs. This role ensures oversight of the portfolio, alignment with global goals, and serves as the regional representative at Global Program Level and Governance boards.
What You'll Do
- Define operational strategy for assigned clinical programs and translate it into concrete steps for operational implementation.
- Build long-term indication level operational plans in collaboration with regional and country stakeholders.
- Drive Program strategy and indication knowledge in team and adapt operations accordingly.
- Ensure knowledge of the global marketplace and competitors is used to create operational competitive strategies and define objectives around emerging patient needs.
- Ensure consolidation, oversight, and forecast of key trial conduct milestones.
- Liaise with other program Regional Program Leads and Regional Feasibility Leads during feasibility for overlapping indications/populations.
- Provide leadership to the Regional Clinical Study Managers for the delivery of clinical trials within timelines, budget, and appropriate inspection readiness quality.
- Be responsible for country selection on studies in collaboration with the Regional Clinical Study Manager and based on feasibility.
- Be the counterpart of the Global Clinical Program Lead at the regional level.
- Represent the region in discussions at Global Program Level and Governance boards.
- Manage interactions with regional program level stakeholders (e.g., Medical Affairs, Regulatory).
- Interact with regional GCP Compliance as appropriate.
- Lead program level relationship with patient advocacy groups.
- Conduct regular program review meetings as part of the oversight of regional Clinical Study Managers and study deliveries.
- Provide expert knowledge on the execution of clinical trials through deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements.
What We're Looking For
- A Bachelor's degree in a scientific or healthcare discipline and 10+ years of progressive experience in clinical operations within biotech, pharmaceutical, or CRO industry.
- Extensive experience in clinical study/program management at regional or global level.
Nice to Have
- A Master’s degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical, or CRO industry.
Technical Stack
- MS Office
- Project Planning Applications
Team & Environment
You will line manage a group of Regional Clinical Study Managers, providing leadership, management, and/or mentorship for the assigned portfolio. You will contribute to resourcing and capability development related to regional study management and report to your counterpart, the Global Clinical Program Lead, at the regional level. The company culture is built on the values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, and we foster global competencies including teamwork, feedback, inclusion, initiative, an entrepreneurial mindset, and a results-oriented approach.
Work Mode
This role operates in a global capacity.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
