Dianthus Therapeutics is hiring a
Director, Clinical Development Scientist

Summary

The Director, Clinical Development Scientist (CDS) will collaborate on or lead the preparation of clinical study documents, liaise with other functions to enable quality clinical study execution, participate in virtual or on-site initiation meetings, monitor and analyze safety and efficacy data, support design and execution of key elements of the Clinical Development Plan, engage with clinical investigators, review scientific literature and competitive intelligence, and provide support for business development activities. The candidate must have an advanced scientific degree, understanding of general therapeutic principles, knowledge in clinical research methodology, statistics, data analysis and interpretation, ability to clearly communicate orally and in writing, neurology and/or rare disease therapeutic area experience, and strong business acumen.

Requirements

• Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree)
• Understanding of general (specifically rare disease, immunology or neurology) therapeutic principles
• Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
• Familiar with scientific literature searches and weighing of quality peer reviewed data
• Ability to clearly communicate to internal and external stakeholders orally and in writing
• Neurology and/or rare disease therapeutic area experience
• Basics of strategic vs. tactical thinking
• Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc and can proactively integrate multiple perspectives into the clinical development process for best end-results

Responsibilities

• Collaborating on, or leading where appropriate, the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents
• Liaising with other functions to enable quality clinical study execution; Provide input to the study team for country and site feasibility assessments
• Collaborating with the clinical study team in site identification and selection and provide assistance with study start-up activities
• Participating in virtual or on-site initiation (and/or feasibility) meetings
• Monitoring, cleaning, analyzing and reviewing safety and efficacy data to establish the presence or absence of trends and follow up as appropriate
• Supporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities
• Liaising with other functions to arrange external expert consultations, contribute to the development of study concepts, protocol designs, and study essential documents
• Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy. Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures
• Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategy
• Maintaining awareness of internal and external developments that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review
• Supporting development of presentations and publications arising from studies and other relevant initiatives
• Providing support for business development activities, such as due diligence and research collaborations