Medical Director, Clinical Development - Boston, United States - Alexion Pharmaceuticals,Inc.

Alexion Pharmaceuticals,Inc.
Alexion Pharmaceuticals,Inc.
Verified Company
Boston, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Location:
Boston, United States


Job reference:
R-197377

Date posted: 04/16/2024


Position Summary

  • The medical director contributes to a crossfunctional team in the design and execution of one or more clinical studies and provides input to the clinical development plan for an investigational product.

Principal Responsibilities

  • Monitor the completeness and quality of safety and efficacy data
  • Provide medical review of studyrelated documents, such as the protocol, informed consent, clinical study report, safety narratives, laboratory manual, and pharmacy manual
  • Provide medical oversight for investigator meetings and site initiation visits
  • Investigate protocol deviations to determine whether intervention is required
  • Respond to questions from health authorities and institutional review boards/ethics committees
  • Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan

Qualifications

  • Experience in industry or academic clinical or basic science research

Education

  • MD, DO, or equivalent with postgraduate training from an accredited institution
  • Subspecialty training and board certification are highly desirable but not required

Competencies

  • Fluent in written and spoken English language
  • Able to utilize software and operating systems required for training, data management, and presentations
  • Scientific and statistical background to interpret and communicate complex data sets
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