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Associate Director, Clinical Operations

6 hours, 34 minutes ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Dianthus Therapeutics

Dianthus Therapeutics

Dianthus Therapeutics is focused on developing advanced complement antibody therapeutics, specifically engineered to provide targeted treatment for patients with significant unmet medical needs, exemplified by their lead product, claseprubart (DNTH103)...

Pharmaceuticals
11-50
Founded 2019
View All Jobs 6

Description

  • Oversee and direct internal and external clinical operations resources for regional or global clinical studies.
  • Lead or support the planning, budgeting, and study management processes for global clinical trials.
  • Manage CROs, vendors, subcontractors, and other external service providers to ensure deliverables are on time and within budget.
  • Contribute to the operational design, planning, and strategy of clinical trial protocols and development plans.
  • Develop scenario plans and risk-benefit analyses to inform recommendations aligned with corporate strategy.
  • Identify best practices, review measurement systems, and improve operational efficiency within the department.
  • Review and manage resource strategies with internal teams and external partners for global drug development programs.
  • Manage relationships with pharmaceutical partners and suppliers to optimize clinical study delivery.
  • Ensure effective communication and information flow across project and reporting functions.
  • Lead or participate in clinical data review and support clinical submission activities.
  • Support the development and implementation of department-level SOPs for clinical trials and related activities.
  • Interface with Finance, Regulatory Affairs, Legal Affairs, Business Development, and other internal groups.
  • Represent the company at Investigator Meetings.

Requirements

  • Undergraduate degree in Life Sciences preferred, RN degree, or equivalent.
  • Advanced degree preferred.
  • 10+ years of experience in the pharmaceutical or medical device industry as a clinical research professional.
  • Successful project leadership experience with hands-on management of clinical trials from inception to completion.
  • Excellent knowledge of international regulatory requirements and ICH GCP guidelines.
  • Experience in direct line management or matrix team management.
  • Hands-on experience monitoring and managing high-functioning clinical trial project teams.
  • Demonstrated success coordinating external resources for clinical development and working with pharmaceutical partners.
  • Demonstrated ability to manage large, complex budgets.
  • Experience with drug development, clinical development planning, and clinical trial execution.
  • Prior experience using spreadsheets, email, word-processing software, and web-based systems such as EDC, IVR/IWRS, and CTMS.
  • Strong verbal and written communication skills with internal and external stakeholders.
  • Ability to work independently and as part of multiple integrated teams.
  • Ability to multi-task, manage several projects in parallel, and maintain attention to detail.
  • Ability to travel, including internationally, and work across cultures.

Benefits

  • Remote work flexibility is available.
  • Opportunity to work on potentially best-in-class therapies for severe autoimmune diseases.
  • Chance to contribute to a mission focused on improving patients’ lives.
  • Work within a culture centered on continuous innovation and high scientific integrity.

Interested in this position?

Apply directly on the company website

Apply Now

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