Executive Medical Director, Global Patient Safety

This is what you will do:

The Executive Medical Director, Therapeutic Area Head Safety provides global strategic and operational oversight of Alexion’s Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution through leadership of a team of Medical Safety Directors and Safety Scientists. This global team is accountable for the identification, analyses, assessment, communication and risk management of safety issues arising for the assigned product portfolio across their entire lifecycles. The jobholder provides medical and drug safety expertise to oversee and lead decision making based on complex risk/benefit evaluation, pharmacoepidemiological or clinical trial data interpretation, risk assessment and risk mitigation. In this capacity, the jobholder may represent the Global Patient Safety department as a subject matter expert on internal strategic or advisory committees. The jobholder has significant impact on cross-functional goals, including collaborating with the Clinical & Medical organization to enhance the safe and effective use of Alexion products and with the Commercial Organization to increase the probability of regulatory success. The Executive Medical Director, Therapeutic Area Head Safety reports to the Vice President, Global Patient Safety.

You will be responsible for:

Provides Global Patient Safety leadership and contributes to key Alexion governance processes. Accountable for the following:

• Function as therapeutic area safety head managing direct reports across multiple product portfolios
• Contributes as a key member of the safety governance meetings, establishing agendas, areas of focus, and ensuring the committee’s success
• Leads a team of Medical Directors and Safety Scientists, and is responsible for people management activities; coaches, counsels and develops direct reports
• Represents Global Patient Safety at internal strategic and/or advisory/governance committees
• Chairs or participates in internal Safety Review Boards where applicable
• May represent Alexion or act as an external technical resource at DSMB or Regulatory Authority meetings, or at external conferences
  
  
  

Leads, provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned Alexion product portfolio for entire lifecycle (pre and post approval). Accountable for the following:

• Leads a team of Medical Directors, and Safety Surveillance Scientists in identifying, evaluating and facilitating resolution of safety signals, including effective communication of risk management plans
• Provides medical and pharmacovigilance expertise to oversee and lead decision making based on complex risk/benefit evaluation, pharmacoepidemiological or clinical trial data interpretation, risk assessment and risk mitigation
• Partners with internal leaders within Global Patient Safety as well as other Alexion functions and affiliates to deliver integrated pharmacovigilance and risk management support to the Alexion business
• Attends Product Safety Team meetings with Medical Directors on an ad hoc basis to support key decision-making, drive evidence–based conclusions and develop pivotal next steps
• Personally asumes and oversees work carried out on products and/or issues under highest scrutiny from a patient safety or regulatory perspective
• Ensures ongoing and adequate safety surveillance, and timely detection and communication of new safety issues by his/her team
• Ensures timely and adequate generation of aggregate reports, regulatory responses and risk management documentation by team, according to international requirements and internal standards.
• Responsible for ensuring adequate definition and implementation of risk minimization activities for assigned product portfolio
• Is responsible for people management activities; coaches, counsels and develops a proactive-solution oriented approach to safety signal detection, evaluation and resolution
  
  
  

You will need to have:

• MD or equivalent degree required
• 10 years extensive relevant safety and risk management experience in the pharmaceutical, biotech or CRO industry
• Demonstrated competence as a results-driven leader to drive teams to foster a proactive solution oriented to safety signal detection, evaluation and risk management
• Thorough knowledge and understanding of safety deliverables, standards and processes at a global level; including pre and post launch experience
• Excellent interpersonal, analytical, managerial, and organizational skills
• Strong verbal and written communication including making recommended courses of action to cross-functional senior leaders that impact the discipline, department or line, and influences their decisions
• Ability to navigate across a matrixed environment and influence cross-functional senior leaders on decision-making (e.g. Clinical Development, Medical Affairs, Regulatory Affairs)
• Sound judgment to filter information and weigh multiple factors in order to make decisions to ensure the safety of products for patients
• Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
• Demonstrated ability to motivate, mentor, influence and collaborate with others in a complex global organizational matrix
• Knowledge and understanding of US and EU safety regulations pre- and post- marketing
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
  
  
  

We would prefer for you to have:

• Rare, Ultra-Rare or Orphan Disease Area experience
• Excellent, independent judgment based on leading-edge knowledge and expertise
• Excellent speaking skills, industry conference speaking experience and profile
• Excellent, independent judgment based on knowledge and expertise
• Strong personal time-management and project-management skills
• Mastery of Microsoft Word, PowerPoint and Excel