Senior Medical Director, Drug Safety
2 weeks ago
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.
QualificationsRequired Skills
Doctor of Medicine degree and clinical care experience, preferably within the field of neurology
Minimum 5+ years experience in the pharmaceutical industry and/or clinical care setting
Direct experience in global medical safety processes and team management
Demonstrated team and cross functional leadership
Demonstrated ability to work with efficiency and organization
Preferably has prior experience in pharmacovigilance or clinical development.
Knowledge of pre- and post- marketing US and EU regulations
Strong communication skills, scientific acumen, and the ability to work across the development functions
#LTD-1
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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