The Senior Medical Director, Therapeutic Area Lead, Global Medical Safety, is responsible for overseeing benefit risk strategy for a portfolio of marketed products and clinical development products. The individual must demonstrate agility, ability to prioritize, and the capability to function at a high level across multiple disease areas. Must be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds throughout the life cycle. The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities, and is expected to be able to influence the strategic direction of complex issues for assigned therapeutic area.
She/he is accountable for the management and mentoring of direct reports including product global safety officers, and other product safety physicians. She/he is responsible for review and approval of key safety documents/deliverables (e.g. DCSI/CDS, DSUR, safety section of phase 3 CSRs, regulatory safety responses and safety content for external communications). This individual will also be accountable for performing and overseeing business development evaluations and recommendations from Global Medical Safety. Finally, the individual will be responsible for continued process improvement within the Global Medical Safety function. Strong communication skills, scientific acumen, and the ability to work in a dynamic matrixed environment are key traits for an individual in this role.

Key Responsibilities:
• Responsible for the leadership and oversight of therapeutic area(s) and management of physicians who serve as the Global Safety Officers (GSO) or Safety MDs for both developmental and marketed compounds in designated therapeutic area (s)
• May be appointed as Global Safety Officer for one or more products
• Responsible for building and developing teams of Global Medical Safety physicians
• Keep upper management informed of key benefit/risk issues for assigned therapeutic areas
• Oversee preparation and presentation by GSOs to the Safety Monitoring Committee.
• Directly responsible/ oversees the medical safety evaluation of projects for new business development
opportunities (e.g., due diligence evaluations).
• Develops and maintains relationships with leaders in Global Safety and Regulatory Sciences, Clinical Development, Pre-Clinical Safety, Research, Global Development, Worldwide Medical.
• Oversees accurate and timely completion and reporting of periodic safety reports and safety regulatory responses;
oversees risk management plans
• May serve as delegate for VP, Global Medical Safety at internal cross functional meetings
• As a leader in the Global Medical Safety department, contribute to continuous improvement in departmental
processes and functions
• May represent Global Medical Safety or act as a technical expert at external meetings, DSMB, or regulatory
authority meetings

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