This is what you will do:
The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for the assigned therapeutic areas in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution through the leadership of a team of Medical Safety Directors and Safety Surveillance Scientists. This global team is accountable for the identification, analysis, 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 the 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 a 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.
Provides Global Drug Safety leadership and contributes to key Alexion governance processes. Accountable for the following:
Leads provide input and oversight of the ongoing safety surveillance, benefit-risk assessment, and risk management activities for the assigned Alexion product portfolio for the entire lifecycle (pre and post-approval). Accountable for the following:
You will need to have:
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.
Alexionis 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,Alexionhas 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).Alexionalso 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.Alexionfocuses 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 inBoston, Massachusetts,Alexionhas offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: .
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.