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Alexion Pharmaceuticals Diagnostic Leader (Possibly Virtual/Remote) in Boston, Massachusetts

  • This position can be based from any of the following Alexion locations; San Francisco, CA, Boston, MA, New Haven, CT, or Blue Bell, PA or be remote/virtual, based anywhere in the United states and may require up to 20% travel.

Position Summary

Join the founding members of Alexion’s new Diagnostic Center of Excellence. Focused on creating better diagnostic tests for patients with rare diseases, we are seeking scientists with expertise in diagnostic discovery and development, and a willingness to learn about complex rare diseases. You will work closely with Global Development Teams and Research to guide diagnostics efforts within Alexion and in collaboration with external partners. In this highly visible role, you will have the opportunity to build new capabilities within Alexion and to influence diagnostic strategy for fast-moving clinical programs. At Alexion, we know that rare disease patients frequently face a challenging diagnostics odyssey and our mission is to change that.

The successful candidate will have a demonstrated ability to manage multiple complex projects and will have previous experience or advance understanding of the development and execution of in vitro diagnostic and device development, as well as an understanding of clinical development. The ideal candidate also has in-depth understanding of global regulatory guidance for diagnostic approval. The Diagnostic Leader is responsible for communication, coordination, and integration of information across multiple functions, as well as management and forecasting of budget for their projects.

Job Duties & Responsibilities

  • Represent the Diagnostics Center of Excellence in Global Development Teams and Therapeutic Area teams.

  • Pull together a diverse set of cross functional stakeholders throughout the organization to develop diagnostic strategy and detailed plans and work closely with subject matter experts across Alexion’s Research, Development and Commercial organizations to create and implement diagnostic solutions

  • Serve as technical subject matter expert on diagnostic technologies and strategies

  • Oversee the day-to-day work of diagnostic programs, and in some cases provide program management for those efforts, typically working closely with a program manager.

  • Lead project based diagnostic sub teams as needed to deliver project and diagnostic objectives

  • Develop a deep understanding of targeted disease areas to inform diagnostic development

  • Develop a deep understanding of multiple technical areas and technologies likely to be explored in diagnostic development

Essential Qualifications

  • 10+ years in a pharmaceutical/diagnostic environment with a minimum of 3+ years in both

  • PhD or equivalent education and experience

  • Exceptional demonstrated partnership, collaboration and communication skills and experience working with diverse teams across the drug discovery, development, and launch spectrum

  • Excellent understanding of biomarkers and diagnostics, including regulatory pathways

  • Demonstrated capability to deeply understand disease and scientific areas. Rare disease experience is not required but is a plus.

  • Experience with assay and diagnostics development including IVD and companion diagnostics

  • Strong collaboration skills and experience in effectively managing CROs

  • Strong knowledge and experience of the drug discovery and development process

  • Strategic agility and ability to adapt to the evolving competitive landscape

  • Leadership experience, with a delivery mindset. Ability to do the work themselves when necessary, self-starter

Required Qualifications

  • Experience interacting with regulatory authorities

*LI-MW1

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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.

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