Medical Director, Global Safety

Summary

Join Biogen as the Medical Director, Global Medical Safety and lead global pharmacovigilance for marketed and investigational products. You will manage safety surveillance, analyze safety data, provide safety strategic leadership for clinical development programs, and build relationships with cross-functional teams. This role requires strong communication, scientific acumen, and the ability to work across development functions. The ideal candidate will have an MD, 3+ years of pharmaceutical industry or clinical care experience, and knowledge of US and EU regulations. Biogen offers a competitive salary, LTI grants, and a comprehensive benefits package.

Requirements

• MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred
• Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting
• Knowledge of pre- and post- marketing US and EU regulations
• Strong communication skills, scientific acumen, and the ability to work across the development functions are key traits for a Medical Director in this group
• Capacity and willingness to work effectively across disease areas
• The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills

Responsibilities

• Manage safety surveillance for assigned products and collaborate with PV scientists and other stakeholders
• Conduct analyses of safety trial data. Ensure adequacy of summarizing and handling of adverse events for investigational and/or marketed Biogen products including decisions on seriousness, expectedness, and causality
• Provide safety strategic leadership for clinical development programs
• Integrate the safety scientific component to building a strategic framework for clinical development plans
• Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, and Worldwide Medical
• Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities

Preferred Qualifications

Preferably has prior experience in pharmacovigilance or clinical development

Benefits

• Biogen’s LTI grants and other incentive programs
• Medical, dental, life, long and short-term disability insurances
• Vacation
• End-of-year shutdown
• 401K participation and matching contributions