BeOne Medicines

Senior Director, Global Clinical Process Management

BeOne Medicines

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $202,200 - $272,200 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • The Head of Global Clinical Process Management is responsible for designing, implementing, and optimizing processes across multiple locations or regions.
  • Analyze existing processes, identify areas for improvement, and implement changes to enhance efficiency and quality.
  • Collaborate with various teams cross functionally and partner with all functions across Clinical Development and Global Process Owners (GPOs).
  • Shape and execute a continuous improvement plan for end-to-end clinical trial processes owned by Global Clinical Operations.
  • Monitor, study management, identifying areas for improvement, designing and implementing process improvements, and leading process improvement teams.
  • Assess, plan, and implement global processes, strategies, and solutions for Clinical Operations.

Requirements

  • Bachelor’s Degree with minimum of 12+ years of experience in pharmaceutical or biotechnology drug development
  • Mid/large pharma experience (preferably clinical operations, process, quality, or compliance roles)
  • ICH GCP subject matter expert
  • Knowledgeable of regulatory requirements (e.g., FDA, MHRA/EMA)
  • Experience working in a cross-functional, global environment
  • Strong written and verbal communication skills
  • Deep experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, project management)
  • Strong leadership, collaboration, and influencing skills in a complex, matrix environment including team leadership or project management
  • Experience in clinical trial process design, harmonization/optimization, and implementation
  • Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvement
  • Six Sigma certification and/or experience with process mapping tools (e.g., Visio, Power Point) desirable.
Benefits
  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial processesprocess improvementprocess designharmonizationoptimizationdata managementbiostatisticsproject managementregulatory requirementsclinical research
Soft skills
communication skillsleadershipcollaborationinfluencing skillscross-functional teamworkproblem-solvinganalytical skillsstrategic planningorganizational skillscontinuous improvement
Certifications
Six Sigma certification