Dianthus Therapeutics - Senior Director, Clinical Development
Requirements
• MD with board certification in US, with clinical experience in Immunology or Rheumatology. • 8+ years of previous experience in clinical research in the CRO/ biotech/ pharma setting preferred. Experience in rare diseases, neurology is highly preferred. • Proven ability to work with cross functional teams, study vendors and clinical trial sites. • Strong business communication skills, written and verbal, and comfortable with giving presentations internally and externally. • 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
• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program. • Leading development of clinical sections of trial and program level regulatory documents. • Driving execution of the program and/or clinical trial in partnership. • Supporting the Vice President, Clinical Development by providing medical input into Clinical Development Plan (CDP) and Clinical Trial Protocol (CTP) reviews and contributing to/driving development of disease clinical standards for new disease areas. • Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process. • Leading the protocol development for the new selected indication/s, working closely with the relevant external and internal stakeholders. • As a medical specialist, supporting and leading interactions with external and internal partners and decision boards. • Medical monitoring of the assigned clinical trial/s, data and safety review and working closely with the clinical operations, and external partners to oversee conduct of the assigned clinical trial/s. • Working closely with the internal and external stakeholders as well as the clinical sites, and investigators to help ensure timely recruitment.
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