Alexion Pharmaceuticals, Inc.
Position Summary The Executive Medical Director, Risk Management Pharmacovigilance provides global strategic and operational oversight of Alexion\u2019s Pharmacovigilance Global Risk Management activities; in fulfillment of global legislation and regulations. The jobholder defines the Risk Management strategy and ensures its execution through leadership of a team of Risk Management Medical Directors. This global team is accountable for the identification, communication and risk management of safety issues arising across all therapeutic area products and programs across their lifecycles. 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, Risk Management Pharmacovigilance reports to the Vice President, Global Pharmacovigilance and Drug Safety and serves as a member of that leadership team. Job Duties & Responsibilities Leads the development, implementation, and management of Risk Management plans for all Alexion pre and post-approval products globally. Accountable for the following: Leads a team of Medical Directors, Risk Management 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 Pharmacovigilance and 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 decision-making, drive evidence \u2013based conclusions and develop pivotal next steps Is responsible for people management activities; coaches, counsels and develops a proactive-solution oriented approach to safety signal detection, evaluation and resolution Provides direct oversight of Risk Management activities for a portfolio of products or programs. Accountable for the following: Chairs key Products Safety Management Teams Leads team decision-making on complex risk\/benefit evaluation and argumentation, pharmacoepidemiological or clinical trial data or interpretation, risk assessment and risk mitigation, making use of preclinical and CMC evidence as well as human data from all sources Provides Global Pharmacovigilance leadership and contributes to key Alexion governance processes. Accountable for the following Serves as a member of the Global Pharmacovigilance and Drug Safety leadership team, contributing to the direction of the Pharmacovigilance functional strategy Contributes as a key member of the Global Safety Committee leading meetings, establishing agendas, areas of focus, and ensuring the committee\u2019s success Represents Global Pharmacovigilance and Drug Safety at internal and advisory\/governance committees May represent Alexion or act as an external technical resource at DSMB or Regulatory Authority meetings as well as through pharmaceutical industry conferences Essential Qualifications MD Required 10 years extensive relevant pharmaceutical industry experience, in the safety and risk management area, including in signal detection, validation and management 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 PV deliverables, standards and processes at a global level; including pre and post launch experience 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 collaborate with internal and external leaders to ensure consistency of actions and decision-making 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 Preferred Qualifications Rare, Ultra-Rare or Orphan Disease Area experience Excellent speaking skills, industry conference speaking experience and profile *LI-CS1 Boston, MA, United States Some opportunities happen only once in a lifetime \u2013 like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion\u2019s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.
Alexion Pharmaceuticals, Inc.
Website : http://www.alexion.com
Alexion Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with severe and life-threatening diseases that are also ultra-rare. Patients with these devastating diseases often have no effective treatment options, and they and their families suffer with little hope.