Alexion Pharmaceuticals Executive Director, Hematology in Boston, Massachusetts
Global Medical Lead responsible for driving the development and scientific understanding of Alexion’s transformative therapies
Drive the development and successful execution of clinical research strategies to clearly define the benefit to risk profile of our products
Advance the understanding of the pathophysiology of rare and orphan diseases and the impact our therapies have on them through scientific discourse and interpretation of data
Represent Alexion science and clinical development expertise to the internal (R&D management, cross functional development teams and executive committee) and external (academic, regulatory, and medical) communities
Oversees a cross functional medical sciences team which
Develops the clinical components of the Product Development Plan
Coordinates communications and planning between medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical Science) as it relates to clinical development study design, execution and interpretation of results.
Oversees the writing of the clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses
Serves as the medical expert on the global product labeling team
Serves as lead internal authors for scientific publication of clinical development studies
Provides scientific and medical input (consultative services) to other R&D, commercial, translational, medicine and business development functions and leads and or oversees clinical activities to support due diligences
Supports the prioritization within the assigned franchise of interest
Acts as either the “defacto” or “official” therapeutic area head as needed
10+ years of experience in clinical development; clinical research, global regulatory, and product development expertise, MD (preferred) or PhD (by exception) required
Direct experience in the development of medical content for regulatory document, and responses (including but not limited to New Drug Applications (NDA) / Biologic License Applications (BLA), or supplemental (s) NDAs/BLAs, briefing packages and common technical documents
Medical Doctorate or equivalent
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.