Associate Director, Clinical Operations at Dianthus Therapeutics - ScoutJobs - The AI-curated global job board
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Posted 3 hours ago

Associate Director, Clinical Operations

Dianthus TherapeuticsAssociate Director, Clinical Operations

Requirements

Undergraduate or RN degree, 10+ years pharmaceutical industry experience, ICH GCP knowledge, Budget management experience, EDC, IVR/IWRS, CTMS proficiency

Skills

Clinical ResearchGCP

About the role

About the Company

Dianthus Therapeutics is developing potentially best in class therapies for patients living with severe autoimmune diseases. Their lead antibody and clinical candidates are engineered for improved potency and patient-friendly, self-administered subcutaneous injections.

Responsibilities

  • Oversee and direct internal and external clinical operations resources for global clinical studies
  • Lead planning, budgeting, and study management processes
  • Manage external service providers including CROs, vendors, and subcontractors
  • Contribute to the operational design, planning, and strategy of clinical trial protocols
  • Perform scenario planning and risk-benefit analyses to align with corporate strategies
  • Manage relationships with pharmaceutical partners and suppliers to optimize delivery
  • Support the development and implementation of department-level SOPs
  • Interface with Finance, Regulatory Affairs, Legal Affairs, and Business Development departments
  • Represent the company at Investigator Meetings

Requirements

  • Minimum of Undergraduate degree (Life Sciences preferred) or RN degree
  • 10+ years of experience in pharmaceutical or medical device industry as a clinical research professional
  • Proven experience in project leadership and hands-on managerial roles running clinical trials
  • Excellent knowledge of international regulatory and ICH GCP guidelines
  • Experience in direct line management or matrix team management
  • Demonstrated ability to manage large, complex budgets
  • Proficiency with EDC, IVR/IWRS, and CTMS systems
  • Ability to travel internationally and work across cultures
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Associate Director, Clinical Operations

Dianthus Therapeutics · Completely Remote

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