Medical Director, Clinical Development Neurology

Alexion•Boston, MA
•Hybrid

About The Position

The Medical Director, Clinical Development, may lead or support the clinical subteam and global program team in constructing global clinical development plans and contributing to asset-level and therapeutic-area strategies. The role is part of the Cell Therapy team and reports to the Senior Medical Director, Hematology. It involves designing and executing multiple clinical studies or programs; representing Clinical Development on the Global Program Team and in management and review committee presentations; and working with clinical study teams on study documents, publications, presentations, and regulatory materials. The role also evaluates disease and competitive landscape information and uses it to inform clinical development programs, asset plans, and therapeutic-area strategy. The position is generally conducted in an office environment, with an expectation to work in the office at least three days per week. Employees must be able to perform typical office-based duties, with or without accommodation, including computer use, communications, problem solving, analysis, collaboration, and availability during standard business hours.

Requirements

  • MD or international equivalent; a neurology specialty is preferred.
  • At least 3 years of clinical experience, preferably within industry.
  • Experience as a medical monitor for clinical trials.
  • Publication in peer-reviewed journals.

Nice To Haves

  • Board certification.
  • Knowledge of the assigned therapy area and ability to interpret, discuss, and represent trial- or program-level data.
  • At least 5 years of industry experience in clinical development.
  • Experience handling medical responsibilities on a cross-functional team.
  • Basic statistical knowledge.
  • Understanding of general and specific therapeutic principles.
  • Experience designing industry-sponsored clinical trials.
  • Broad experience in clinical trial methodology, statistics, data analysis, and interpretation.
  • Experience authoring essential study documents, Clinical Study Reports, and regulatory documents.

Responsibilities

  • Design and execute multiple clinical studies or clinical programs.
  • Represent Clinical Development on the Global Program Team and present at management and review committees.
  • Work with clinical study teams to prepare clinical study documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
  • Select appropriate advisory board participants and guide the team in preparing for meetings.
  • Evaluate information about relevant diseases and the competitive landscape, and synthesize it to support clinical development programs, asset plans, and therapeutic-area strategy.

Benefits

  • Qualified retirement programs.
  • Paid time off, including vacation, holidays, and leaves.
  • Health coverage.
  • Dental coverage.
  • Vision coverage.
  • Eligibility for short-term incentive bonuses and equity-based awards for salaried roles.

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What This Job Offers

Job Type

Full-time

Career Level

Director

Education Level

Ph.D. or professional degree

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