Alexion Pharmaceuticals Medical Director, Thrombosis Clinical Development Sciences (Possible Virtual/Remote) in Boston, Massachusetts
Seeking an individual who is Board Certified in Internal Medicine with 3-5 years of industry experience. This individual will serve as a medical expert for the study team and medical monitor for phase 2-4 clinical trials. This position additionally offers substantial opportunities for regulatory and commercial interactions and career advancement in the fast-moving area of rare disease.
Job Duties & Responsibilities
Medical Expert for clinical study team
Protocol development from concept to final protocol
Strategic guidance to phase II/III development programs and oversight of global clinical trials/trial team (s) on assigned program(s)
Presentation at academic congresses, investigator meetings and advisory meetings
Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
DMC development and liaison
Medical oversight of commercial documents
MD or equivalent
Board Certified in Internal Medicine or Thrombosis
Minimum 3-5 years of industry experience
Previous history running clinical trials
Safety medical monitoring and reporting experience
Protocol development experience
Basic statistical knowledge
Excellent written / oral communication skills
Ability to think strategically
Willingness to take on new responsibilities
Interest in career progression and ability to take on a more senior roles in 1-3 years
History of academic clinical or basic science research
Business development experience
Publication in peer reviewed journals
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.
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.