Associate Director, Clinical Operations

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 16%

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2017

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

Healthcare • Biotechnology • Pharmaceuticals

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.

📋 Description

• Oversee and direct internal and external clinical operations resources for global clinical studies • Contribute to strategy, tactics, planning, budgeting, study management, and execution of clinical trials • Act as Clinical Project Manager responsible for study implementation, execution, and resource management • Ensure clinical activities comply with applicable regulations, ICH, and GCP guidelines • Oversee patient recruitment, trial site selection, trial plan optimization, and trial execution with a focus on quality • Manage CROs, vendors, subcontractors, suppliers, and pharmaceutical partners • Develop and operationally design clinical trial protocols, study plans, and development plans • Conduct scenario planning and risk-benefit analyses • Identify best practices and improve operational efficiency • Ensure effective communication and information exchange across project and reporting functions • Participate in clinical submission activities and clinical data review • Support development and implementation of department-level SOPs • Interface with Finance, Regulatory Affairs, Legal Affairs, and Business Development • Represent the company at Investigator Meetings

🎯 Requirements

• Minimum of an undergraduate degree (Life Sciences preferred), RN degree, or equivalent • 10+ years of experience in the pharmaceutical or medical device industry as a clinical research professional • Successful project leadership experience 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 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 and understanding of the drug development process, clinical development planning, and clinical trial execution • Understanding of clinical aspects of the therapeutic area and willingness to develop in-depth expertise • Experience using spreadsheets, email, word-processing software, and web-based systems including EDC, IVR/IWRS, and CTMS • Ability to work independently and as a member of multiple integrated teams • Ability to contribute creative yet practical solutions to problems • Ability to multitask and manage several projects in parallel while paying attention to detail • Ability to proactively identify and resolve issues and hurdles affecting trial implementation • Highly effective verbal and written communication skills with internal and external stakeholders • Ability to collaborate effectively with team members • Ability to travel, including internationally, and work across cultures

🏖️ Benefits

• Remote work option • Opportunity to work on potentially best-in-class therapies for severe autoimmune diseases • Opportunity to work with global clinical development programs and cross-functional teams