Senior Director, Clinical Development
Dianthus Therapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
Tech Stack
About the role
- 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.
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.
Benefits
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical leadershipclinical trial protocol developmentmedical monitoringdata and safety reviewliterature reviewKOL interactionsclinical development plandisease clinical standardsregulatory document developmentclinical research
Soft Skills
business communicationpresentation skillsproactivenessmotivationcollaborationopen-mindednessorganizational skillscross-functional teamworkproblem-solvingstakeholder engagement
Certifications
MDboard certification