Director, Clinical Operations - EU Region

December 7

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

2 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

Description

• The Director, Clinical Operations is responsible for the oversight, strategic direction and efficient operational planning and implementation of global clinical trials/programs. • Reporting to the Head of Clinical Operations or Executive/Senior Director of Clinical Operations, you will demonstrate effective leadership and cross-functional team management. • You will be accountable to ensure all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP. • This is a unique opportunity where you have a chance to positively impact lives as part of a team driven by continuous innovation with very high scientific integrity. • We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives.

Requirements

• Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. • Experience in the pharmaceutical or medical device industry as a clinical research professional, including successful project leadership role and hands-on managerial experience running high quality clinical trials from inception to completion. • Excellent knowledge of international regulatory and ICH GCP guidelines. • Experience in direct line management preferred and hands-on experience in monitoring and managing high-functioning clinical trial project teams. • Demonstrated success in coordinating external resources for clinical development and in working with pharmaceutical partners. • Demonstrated ability to manage large complex budgets. • Experience and understanding of the drug development process, clinical development planning and clinical trial execution. • Understanding of clinical aspects of therapeutic area along with willingness to develop in-depth expertise. • Prior experience using computer applications including spreadsheets, email, word-processing software & web-based systems (EDC, IVR/IWRS, CTMS). • Ability to work well independently as well as a member of multiple, integrated teams. • Ability to contribute creative yet practical solutions to problems. • Ability to multi-task and manage several projects in parallel while paying attention to detail. A wide degree of creativity and latitude is expected. • Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion. • Highly effective verbal and written communication skills with internal and external stakeholders. • Effectively collaborates with team members. • Ability to travel (including internationally) and work across cultures.