Director, Global Medical Affairs, Sponsored Phase IV Studies
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:**
+ 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.
Confirm your E-mail: Send Email
All Jobs from BeiGene