Senior Clinical Scientist & Study Lead (Rare Disease)

Travere Therapeutics

Washington (District of Columbia)

Remote

USD 150,000 - 195,000

Full time

4 days ago
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Job summary

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, seeks an Associate Director, Clinical Science to advance clinical development and lifecycle activities in collaboration with cross-functional teams. The role involves design and analysis of translational and clinical data, and ensuring studies adhere to GCP.

The successful candidate will contribute to INDs/NDAs/BLAs, manage deliverables, and communicate findings to internal and external stakeholders, including

Qualifications

  • PhD, PharmD, or MD in a related life science discipline required or equivalent.
  • 4+ years of relevant experience in the pharmaceutical industry; rare disease preferred.
  • Experience supporting clinical trials and clinical studies; human pharmacology studies preferred.

Responsibilities

  • Lead clinical science components of assigned study plans and contribute to protocol design and implementation.
  • Review, interpret, summarize safety and efficacy data; identify questions for the clinical development team.
  • Coordinate activities, timelines, and deliverables across study teams with well-organized documentation.
  • Support study conduct in accordance with protocols and GCP.
  • Lead preparation and scientific review of reports, slides, and ClinicalTrials.gov summaries.
  • Contribute to INDs, NDAs, BLAs, and regulatory submissions with protocols, SAPs, and listings.
  • Build relationships with alliance partners, investigators, and key opinion leaders.
  • Contribute to manuscripts and presentations at scientific meetings.
  • Perform additional duties as needed.

Skills

Clinical study design
Data analysis
Regulatory documentation
Cross-functional collaboration
Communication skills
Project management

Education

PhD/MD/PharmD in life sciences

Job description

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, seeks an Associate Director, Clinical Science to advance clinical development and lifecycle activities in collaboration with cross-functional teams. The role involves design and analysis of translational and clinical data, and ensuring studies adhere to GCP.

The successful candidate will contribute to INDs/NDAs/BLAs, manage deliverables, and communicate findings to internal and external stakeholders, including

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