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 & 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 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
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 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
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)
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
Demonstrated ability to motivate, mentor, influence and collaborate with others in a complex global organizational matrix
This position can be based in Blue Bell, PA, San Francisco, CA, Boston, MA, or remote/virtual.
Clinical experience, a few years in clinical medicine (post-training/residency)
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
Boston, MA, United States
Some opportunities happen only once in a lifetime - 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 global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also 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) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
Alexion Pharmaceuticals, Inc.