The Senior Medical Director 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 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 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 Senior Medical Director reports to the Executive Medical Director, Global Drug Safety.Job Duties & ResponsibilitiesProvides 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 reportsRepresents Global Drug Safety at internal strategic and/or advisory/governance committeesChairs or participates in internal Safety Review Boards where applicableMay represent Alexion or act as an external technical resource at DSMB or Regulatory Authority meetings, or at external conferencesLeads, 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 plansProvides 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 mitigationPartners 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 businessAttends Product Safety Management Teams with Medical Directors on an ad hoc basis to support key decision-making, drive evidence–based conclusions and develop pivotal next stepsPersonally asumes and oversees work carried out on products and/or issues under highest scrutiny from a patient safety or regulatory perspectiveEnsures ongoing and adequate safety surveillance, and timely detection and communication of new safety issues by his/her teamEnsures 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 portfolioIs responsible for people management activities; coaches, counsels and develops a proactive-solution oriented approach to safety signal detection, evaluation and resolutionEssential QualificationsMD or equivalent degree required8 years extensive relevant pharmaceutical industry experience, in the safety and risk management area, including in signal detection, validation and managementDemonstrated competence as a results-driven leader to drive teams to foster a proactive solution oriented to safety signal detection, evaluation and risk managementThorough knowledge and understanding of PV deliverables, standards and processes at a global level; including pre and post launch experienceExcellent interpersonal, analytical, managerial, and organizational skillsStrong 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 decisionsAbility to navigate across a matrixed environment and influence cross-functional senior leaders on decision-making (e.G.
Clinical Development, Medical Affairs, Regulatory Affairs)Ability to collaborate with internal and external leaders to ensure consistency of actions and decision-making with overall functional strategiesSound judgment to filter information and weigh multiple factors in order to make decisions to ensure the safety of products for patientsSound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problemsDemonstrated ability to motivate, mentor, influence and collaborate with others in a complex global organizational matrixThis position can be based in Blue Bell, PA, San Francisco, CA, Boston, MA, or remote/virtual.Preferred QualificationsClinical experience, a few years in clinical medicine (post-training/residency)Rare, Ultra-Rare or Orphan Disease Area experienceExcellent, independent judgment based on leading-edge knowledge and expertiseExcellent speaking skills, industry conference speaking experience and profileDate Posted02-Oct-2024Closing Date30-Jan-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.
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Alexion participates in E-Verify.SummaryLocation: Spain - BarcelonaType: Full time