Sr Director, Clinical Development Sciences Nephrology

The Senior Director, Clinical Sciences will provide medical input to Global Program Teams (GPTs), serve as medical expert for the study team and medical monitor for phase 1-4 clinical trials.

The Senior Director is typically responsible for 1 or more medium sized clinical development programs under the supervision of either an Executive Director or a VP Clinical Development TA Head. In addition, they may also have responsibility for discrete, specific business development efforts (e.g., a due diligence on a specific target).

This position offers substantial opportunities for scientific and commercial interactions and career advancement in the fast-moving area of rare disease.

Job Duties & Responsibilities

• Medical input to the Global Development Team / Subteam
• Medical Expert for clinical study team
• Protocol development from concept to final protocol
• Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
• Scientific interpretation of data from clinical studies
• May supervise other medical monitors on individual studies
• Strategic guidance to phase I/II/III development programs and oversight of global clinical trials/trial team (s) on assigned programs
• Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
• 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
• Providing medical/scientific input to evaluate potential business opportunities
  
  

Essential Qualifications

• MD or equivalent; Board Certification preferred
• 5-10 years of clinical experience preferably within industry (minimum of 3 years of industry experience may be acceptable for outstanding candidates)
• Experience as a medical monitor for clinical trials required
• Regulatory experience preferred
• Publication in peer reviewed journals
• Excellent written / oral communication skills
• Attention to detail and ability to think strategically
• Willingness to take on new responsibilities
• Interest and ability to learn about new therapeutic areas
• Interest in career progression and ability to take on a more senior roles in 1-3 years
  

Preferred Qualifications

• Experience for medical responsibilities on a cross-functional team preferred
• Basic statistical knowledge preferred
  

• LIMW-1

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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 .