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Dianthus Therapeutics, Inc. · 3 months ago

Director, Clinical Development Scientist

Waltham, MA

Full-time

Onsite

Director/Executive

Dianthus Therapeutics, Inc. is developing innovative therapies for patients with severe autoimmune diseases. The Director, Clinical Development Scientist will lead clinical strategy and execution for the Myasthenia Gravis program in the APAC region, ensuring compliance with GCPs and overseeing clinical trial activities.

BiopharmaBiotechnologyHealth Care

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 Clinical Development program lead 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

Qualification

Clinical developmentRare diseases experienceNeurology experienceGCP knowledgeMedical monitoringBusiness communicationProactivenessCollaborationMotivationOpen-mindedness

Required

MD, PhD, or PharmD required

Experience in clinical development is required

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