argenx

United in our commitment to improve the lives of patients

Clinical Operations Development Lead

Clinical OperationsClinical OperationsFull TimeRemoteTeam 1,001-5,000Since 2008H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

158 days ago

Salary

Not specified

Bachelor Degree10 yrs expEnglishEnglishGoogle Cloud Platform

Job Description

• The Clinical Operations Development Lead (CODL) is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset or across all indications for an asset. • Together with the Medical Development Lead (MDL), the CODL co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development Plan (CDP). • Ensures the CDP is endorsed by the AST and the Development Management Committee (DMC) and is executed within agreed timelines and budget. • Provides strategic input and is accountable for all clinical related aspects within the assigned therapeutic indication/program and in line with the agreed timelines, budget and quality standards as outlined in the applicable Standard Operation Procedures (SOPs) and Work Instructions (WIs).

Job Requirements

  • Bachelor's degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
  • Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management)
  • Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry
  • Strong interpersonal and stakeholder management skills
  • Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.

Benefits

  • Health insurance
  • Retirement plans
  • Professional development opportunities

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