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Senior Director, Clinical Development

1 month ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
GCP SAP
Apply Now
Dianthus Therapeutics

Dianthus Therapeutics

Dianthus Therapeutics is focused on developing advanced complement antibody therapeutics, specifically engineered to provide targeted treatment for patients with significant unmet medical needs, exemplified by their lead product, claseprubart (DNTH103)...

Pharmaceuticals
11-50
Founded 2019
View All Jobs 6

Description

  • Provide clinical leadership and strategic medical input for assigned clinical deliverables and programs.
  • Lead development of clinical sections for trial-level and program-level regulatory documents.
  • Drive execution of the clinical program and/or trial in partnership with cross-functional stakeholders.
  • Review and contribute to Clinical Development Plans and Clinical Trial Protocols, and help define disease clinical standards for new disease areas.
  • Conduct literature reviews, engage key opinion leaders, attend scientific meetings, and present the clinical development plan to internal stakeholders.
  • Lead protocol development for selected indications in close collaboration with internal and external stakeholders.
  • Support interactions with external and internal partners and decision-making boards as a medical specialist.
  • Serve as medical monitor for assigned studies, including data and safety review and oversight of trial conduct with clinical operations and external partners.
  • Work with clinical sites, investigators, and stakeholders to support timely recruitment.
  • Guide data interpretation, data mining, and publication activities, including study synopses, investigator brochures, clinical study reports, SAPs, and TLF shells.

Requirements

  • MD with US board certification and clinical experience in Immunology or Rheumatology.
  • 8+ years of clinical research experience in a CRO, biotech, or pharmaceutical setting preferred.
  • Experience in rare diseases and/or neurology is highly preferred.
  • Strong understanding of GCP and regulatory requirements.
  • Proven ability to work with cross-functional teams, study vendors, and clinical trial sites.
  • Strong written and verbal business communication skills, including the ability to present internally and externally.
  • Ability to identify challenges and risks and take appropriate action with limited supervision.
  • Highly motivated self-starter who can organize and perform complex tasks with minimal supervision.
  • Ability to coordinate internal study teams and external vendors as needed.
  • Open to remote work.
  • Experience in auto-immune neurology indications is relevant.

Benefits

  • Remote work is available.
  • Opportunity to join a growing organization with an expanding pipeline.
  • Chance to lead clinical strategy for autoimmune neurology indications.
  • Work on potentially best-in-class therapies for severe autoimmune diseases.

Interested in this position?

Apply directly on the company website

Apply Now

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