Director, Global Medical Affairs, Sponsored Phase IV Studies

Director, Global Medical Affairs, Sponsored Phase IV Studies

BeiGene

Basel, Milan or Remote

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.

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