Director, Global Medical Affairs, Sponsored Phase Iv Studies

vor 2 Wochen

Basel, Schweiz BeiGene Vollzeit

General Description:

- Work with country or global teams to plan and implement Phase IV GMA-sponsored clinical trials, interventional or non-interventional
- This includes all aspects of study management and oversight, including working with the CRO, engaging with non-GMA stakeholders for alignment, project management, data management, safety planning, etc.

Essential Functions of the job:

- Create the global governance structure and implementation process for these studies.
- Build capabilities and infrastructure for GMA-sponsored studies; interventional and non-interventional.
- Build the templates, tracking and reporting process for these studies for leadership and non GMA members.
- Create a global Sharepoint site to house all required documents and oversee all data is added to the appropriate systems (GMA portal, ClinOps portal).
- Work with the responsible party (eg Country Medical Director, HEOR lead) to create the implementation and operations plan for a GMA-sponsored study.
- Create the governance structure and planning forum for each study.
- Manage and track study-specific activities and deliverables.

Education Required:

- Master's or Doctorael level degree required.

Qualifications:

- Master's or Doctorate level degree with 10 + years of experience in the pharmaceutical industry.
- 5 + years of experience in managing company-sponsored clinical trials within the pharmaceutical industry.
- Preferred: Experience conducting post-marketing company-sponsored trials (interventional & non-interventional).
- Experience managing a CRO, understanding of global regulatory requirements for company-sponsored trials.
- Detail-oriented, organized, excellent written & verbal communication skills.
- Able to function in a fast-paced environment, self-directed.

Supervisory Responsibilities:

- Yes

Computer Skills:

- Excel, PowerPoint, Project Management Software, Smartsheet, data management databases (eg CTMS), Veeva or similar.

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity

We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.

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