Medical safety director job description

The Senior Medical Director, Global Medical Safety, oversees the benefit-risk strategy for a portfolio of marketed and clinical development products. The individual must demonstrate agility, the ability to prioritize, and the capability to provide strategic leadership across multiple disease areas and modalities. Must be comfortable working in an entrepreneurial environment to advance compounds' safety and biological understanding through the life cycle. The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community, and global regulatory authorities and is expected to influence the strategic direction of complex issues for the assigned therapeutic areas.

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 continuous process improvement within the Global Medical Safety function. Strong communication skills, scientific acumen, and the ability to work in a dynamic matrixed environment are critical traits for an individual in this role.
What You'll Do:

Responsible for the leadership and oversight of global 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).

Keep upper management informed of key benefit/risk issues for assigned therapeutic areas.

Serve as operational lead for Safety Monitoring Committees in relevant TA, overseeing preparation and presentation by GSOs to the Safety Committee.

Directly responsible for and oversees the medical safety evaluation of projects for new business development opportunities (e.g., due diligence evaluations).

Develops and maintains relationships with leaders in other Biogen functions, including Clinical Development, Pre-Clinical Safety, Research, and Worldwide Medical.

Oversees accurate and timely completion and reporting of periodic safety reports and safety regulatory responses; oversees risk management plans.

Who You Are:

You are an experienced leader within the Global Medical Safety space who can proactively contribute to continuous improvement in departmental processes and functions. You have proven exposure to performing and overseeing business development evaluations and recommendations while effectively managing and mentoring team members.

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