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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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Get started — it's freeAssociate Director, Clinical Operations
Dianthus Therapeutics · Completely Remote
