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BeiGene Director, Global Medical Affairs, Sponsored Phase IV Studies in San Mateo, California

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.

Travel:

  • <10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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