Director, Clinical Development

Summary

Join Dianthus Therapeutics, a clinical-stage biotechnology company, as the Director or Senior Medical Director, Clinical Development. You will play a crucial role in the success of our Phase III trial for CIDP. Leading the preparation and execution of clinical study protocols, data interpretation, and reports, you will act as the lead medical monitor. Collaboration with various teams is essential for developing statistical analysis plans, informed consent forms, and regulatory filings. You will ensure timely recruitment and adherence to GCP principles, while also contributing to medical safety and education. This role offers the opportunity to join a growing organization with remote work flexibility.

Requirements

• MD with board certification in the US
• Knowledge – thorough understanding of GCP/regulatory requirements
• Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision
• Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision
• Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable
• Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions

Responsibilities

• Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical development program
• Lead development of clinical sections of trial and program level regulatory documents including authoring Clinical Trial Protocols and amendments, clinical study reports, statistical analysis plans
• Drive execution of the program and/or clinical trial in partnership with internal and external stakeholders
• Support the Vice President, Clinical Development by providing medical input into Clinical Development Plan for assigned programs
• Conduct literature review, external expert interactions, attend and lead scientific meetings, advisory boards, and investigator meetings, and present the protocol to relevant internal and external stakeholders
• Perform medical monitoring of the assigned clinical trial/s, data and safety review and work closely with the clinical operations, safety physicians, CRO medical monitors, and other external partners to oversee conduct of the assigned clinical trial/s
• Work closely with the internal and external stakeholders as well as developing strategies to help ensure timely recruitment

Preferred Qualifications

• Clinical experience in Neurology or executing neurology clinical trials
• Previous experience leading industry supported clinical research in the pharma/biotech/CRO setting with familiarity with clinical study documentation, processes, and execution
• Strong ability to work with and lead cross functional study teams, study vendors and clinical trial sites
• Strong business communication skills, written and verbal, and comfortable with giving presentations internally and externally

Benefits

We are open to you working remotely