Senior Director, Clinical Operations

February 8

Apply Now

Receive Emails with Similar Jobs

Dianthus Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.

2 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

📋 Description

• Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. • The Senior Director, Clinical Operations is responsible for the oversight, strategic direction and efficient operational planning and implementation of global clinical trials/programs. • You will demonstrate effective leadership and cross-functional team management that accelerates development of assets, in support of Dianthus Myasthenia Gravis studies and future studies as assigned. • You will be accountable to ensure all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and is responsible to oversee and manage internal and external resources to ensure efficient patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality. • This is a unique opportunity where you have a chance to positively impact lives as part of the 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. • We are open to you working remotely.

🎯 Requirements

• Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. • 10-15 years of 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.