What are the responsibilities and job description for the Director, Global Medical Affairs, Sponsored Phase IV Studies position at BeiGene?
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 :
Computer Skills :
Travel :
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.
