Senior Medical Director, Drug Safety

Biogen - City Of Cambridge
new offer (27/06/2024)

job description

Job Description
About This Role
The Senior Medical Director, Drug Safety is responsible for oversight of safety processes for Biogen marketed and in-development products, including signal detection;
aggregate reporting;
cross functional trial design, implementation, and management;
and team member management and career development.
What You’ll Do
Manage direct reports and facilitate their career development
Oversee product-related signal detection plans and safety documents
Oversee and approve creation and updates of safety-related regulatory submissions and aggregate reports
Oversee management Biogen clinical trial adverse event data
Ensure adequate recording, summarizing, and handling of serious adverse events in Biogen clinical trials
Oversee safety physicians leading safety issues through corporate governance processes
Spearhead and strategize for safety-related research initiatives
Evaluate and provide input toward updates of internal safety processes
Effectively communicate ideas, strategies, and updates within and across corporate functions
Communicate questions and concerns effectively and efficiently with safety leadership
Evaluate and advise on safety data in drug candidate acquisition processes
Who You Are
You demonstrate the flexibility and capability to lead and manage a team of physicians functioning at a high level across multiple disease areas and have a record of working in an entrepreneurial environment to advance the safety and biological understanding of compounds through their life cycles.

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