Director, CX Learning & Knowledge
Rula
Director, Clinical Development Scientist
Dianthus Therapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud Platform
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 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.
Requirements
- MD, PhD, or PharmD required
- Experience in clinical development is required. 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
- Health insurance
- Professional development opportunities
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical leadershipclinical developmentregulatory documentsprotocol developmentmedical monitoringdata reviewsafety reviewliterature reviewdisease clinical standardsKOL interactions
Soft skills
business communicationpresentation skillsproactivenessmotivationcollaborationopen-mindednessorganizational skillsproblem-solvingteamworkinterpersonal skills
Certifications
MDPhDPharmD
