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Associate Director, Biomarkers

Company: Alexion Pharmaceuticals, Inc.
Location: New Haven
Posted on: September 14, 2020

Job Description:

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. Career Opportunities: Associate Director, Biomarkers (22204)

Req Id 22204 - Posted 09/09/2020 - United States - New Haven, CT - Research

Position Summary

We are looking for an innovative team leader to lead a group of scientists to support biomarker development for Alexion's programs. Responsibilities include overseeing the identification and selection of proper biomarkers for intended uses, development of a biomarker plan, which may consist of developing and validating biomarker assays for diagnostic, prognostic, and response to treatment methodology. The Associate Director provides scientific, technical, and operational leadership to enable crucial decision making. Additional responsibilities include managing budgets, timelines, and resources as well as mentoring the career growth of each direct report. The successful individual will set high standards of accountability, quality, and compliance.

Principal Responsibilities

* Function as a subject matter expert in the area of biomarker research in one or more rare diseases and may include Hematology, Neurology, and Metabolic disorders.

* Lead a program or project as Biomarker lead at any stage of clinical development

* Create a culture and environment of compliance, continual improvement, and high productivity

* Supervise and manage a Biomarker sub-team to support nonclinical and clinical studies by developing and qualifying/validating biomarker assays as appropriate

* Responsible for the preparation of biomarker sections of clinical study protocols and reports

* Lead the interpretation of biomarker data provided to project teams and Alexion governance bodies

* Manage direct reports, mentor and ensure opportunities are made available for career growth

* Manages resources, budgets, and timelines to ensure on-time delivery of high-quality data and that reports are written and documentation finalized to protect intellectual property.

Qualifications

* 5+ years of biopharmaceutical R&D experience in drug development and participation in projects involving cross-functional teams

* Experience in leading multiple biomarker programs in which biomarkers are proposed, analyzed and results interpreted as a part of a testable hypothesis to provide information that correlates with clinical response to treatment, provides direction to the project team and drives critical decision making

* Extensive knowledge and expertise in biomarker platforms, equipment, and sample processing techniques (animal tissue, cultured cells, blood) for extracting/detecting proteins and oligonucleotides as well as data analysis software and basic statistical analysis

* Experienced with developing cell-based and solid-phase methodologies for detecting analytes in the complex matrix (i.e., serum, plasma, urine) including immunoassays, Luminex, western blot, flow cytometry, microscopy, RT-qPCR, etc.

* Knowledgeable of regulatory guidance and "fit-for-purpose" biomarker validation for supporting clinical studies.

* Excellent organizational skills and ability to prioritize tasks based on project timelines, and capable of handling multiple tasks/projects simultaneously

* Excellent written, verbal, and visual communication skills, as evidenced by a track record of publications, posters, and/or presentations.

Education

* MD, or Ph.D.in biology or relevant biological sciences with a minimum of 5 years of experience in biomarker discovery and development.

*LIDI-1

New Haven, CT, 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. * 5+ years of biopharmaceutical R&D experience in drug development and participation in projects involving cross-functional teams

* Experience in leading multiple biomarker programs in which biomarkers are proposed, analyzed and results interpreted as a part of a testable hypothesis to provide information that correlates with clinical response to treatment, provides direction to the project team and drives critical decision making

* Extensive knowledge and expertise in biomarker platforms, equipment, and sample processing techniques (animal tissue, cultured cells, blood) for extracting/detecting proteins and oligonucleotides as well as data analysis software and basic statistical analysis

* Experienced with developing cell-based and solid-phase methodologies for detecting analytes in the complex matrix (i.e., serum, plasma, urine) including immunoassays, Luminex, western blot, flow cytometry, microscopy, RT-qPCR, etc.

* Knowledgeable of regulatory guidance and "fit-for-purpose" biomarker validation for supporting clinical studies.

* Excellent organizational skills and ability to prioritize tasks based on project timelines, and capable of handling multiple tasks/projects simultaneously

* Excellent written, verbal, and visual communication skills, as evidenced by a track record of publications, posters, and/or presentations., * MD, or Ph.D.in biology or relevant biological sciences with a minimum of 5 years of experience in biomarker discovery and development. 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.

Keywords: Alexion Pharmaceuticals, Inc., New Haven , Associate Director, Biomarkers, Other , New Haven, Connecticut

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