Clinical Scientist Lead, Rare Disease Trials (Remote)

Travere Therapeutics; Atlanta (GA); Hybride; USD 150 000 - 195 000; Plein temps

Résumé du poste

Travere Therapeutics is seeking an Associate Director, Clinical Science, to support ongoing and future clinical development. You will work with cross-functional teams on study design, analyses, and regulatory content, ensuring adherence to GCP and high scientific standards.

The role involves collaboration with partners, investigators, and internal teams to deliver trials, data analyses, and regulatory submissions for rare diseases.

Qualifications

• PhD/MD/PharmD in life sciences required; combo with experience may be considered.
• 4+ years in the pharmaceutical industry with clinical trial exposure.
• Experience supporting INDs, NDAs, or regulatory information requests preferred.

Responsabilités

• Lead clinical science components of study plans and protocol design.
• Review and summarize clinical trial safety and efficacy data for discussions.
• Coordinate activities across study teams with documentation.
• Support study conduct per protocols and GCP requirements.
• Lead preparation and scientific review of reports and regulatory materials.
• Contribute to IND/NDA/BLA submissions and regulatory responses.
• Build relationships with alliance partners, investigators, and leaders.
• Contribute to manuscripts and scientific presentations.

Connaissances

Cross-functional collaboration

GCP knowledge

Data interpretation

Regulatory submissions knowledge

Formation

PhD/MD/PharmD in life sciences

4+ years pharma/biotech experience

Clinical trials experience

Description du poste

Travere Therapeutics is seeking an Associate Director, Clinical Science, to support ongoing and future clinical development. You will work with cross-functional teams on study design, analyses, and regulatory content, ensuring adherence to GCP and high scientific standards.

The role involves collaboration with partners, investigators, and internal teams to deliver trials, data analyses, and regulatory submissions for rare diseases.