Senior Medical Director Global Patient Safety
Senior Medical Director Global Patient Safety
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Job Description
The Senior Medical Director provides global strategic and operational oversight of Alexions 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 through leadership of a team of Medical Safety Directors and Safety Surveillance 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 Drug Safety department as a subject matter expert on internal strategic or advisory committees. The jobholder has significant impact on crossfunctional 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 Senior Medical Director reports to the Executive Medical Director Global Drug Safety.
Job Duties & Responsibilities
- Provides Global Drug Safety leadership and contributes to key Alexion governance processes. Accountable for the following:
- Leads a team of Medical Directors and Safety Surveillance Scientists and is responsible for people management activities; coaches counsels and develops direct reports
- Represents Global Drug 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 Drug Safety as well as other Alexion functions and affiliates to deliver integrated pharmacovigilance and risk management support to the Alexion business
- Attends Product Safety Management Teams with Medical Directors on an ad hoc basis to support key decisionmaking drive evidencebased 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 proactivesolution oriented approach to safety signal detection evaluation and resolution
Essential Qualification
- MD or equivalent degree required
- 8 years extensive relevant pharmaceutical industry experience in the safety and risk management area including in signal detection validation and management
- Demonstrated competence as a resultsdriven leader to drive teams to foster a proactive solution oriented to safety signal detection evaluation and risk management
- Thorough knowledge and understanding of PV 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 crossfunctional senior leaders that impact the discipline department or line and influences their decisions
- Ability to navigate across a matrixed environment and influence crossfunctional senior leaders on decisionmaking (e.g. Clinical Development Medical Affairs Regulatory Affairs)
- Ability to collaborate with internal and external leaders to ensure consistency of actions and decisionmaking with overall functional strategies
- 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
Preferred Qualification
- Clinical experience a few years in clinical medicine (posttraining/residency)
- Rare UltraRare or Orphan Disease Area experience
- Excellent independent judgment based on leadingedge knowledge and expertise
- Excellent speaking skills industry conference speaking experience and profile
Date Posted
03Feb2025Closing Date
30May2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.
Required Experience:
Exec
Employment Type
Full-Time
