Remote Associate Director, Clinical Science – Rare Disease

Travere Therapeutics; Minneapolis (MN); Hybrid; USD 150.000 - 195.000; Vollzeit

Zusammenfassung

Travere Therapeutics, based in San Diego, seeks an Associate Director of Clinical Science to support ongoing and future clinical development. You will lead study design, data analyses, and regulatory submissions while coordinating cross-functional teams and ensuring adherence to GCP standards.

Ideal candidates hold a PhD/MD/PharmD with 4+ years in pharma, and have experience supporting clinical trials. Occasional domestic and international travel (up to 15%) is expected; some onsite work in San

Qualifikationen

• PhD, PharmD, or MD required; equivalent combination of education and applicable job experience may be considered.

Aufgaben

• Lead clinical science components of assigned study plans and protocol design, including human pharmacology studies.
• Review, interpret, summarize clinical trial safety and efficacy data; identify findings for discussion with the clinical development team.
• Coordinate assigned clinical science activities, timelines, and deliverables across study teams, maintaining accurate and well-organized documentation.
• Support study conduct in accordance with protocols, applicable regulations, and Good Clinical Practice (GCP).
• Lead the preparation and scientific review of clinical and data analysis reports, slide presentations, and ClinicalTrials.gov summaries in collaboration with internal and external partners.
• Contribute clinical, scientific, and mechanism-of-action content to INDs, NDAs, BLAs, and related submissions, including protocols, statistical analysis plans, mock tables, figures, and listings, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit-risk assessments, regulatory briefing books, and responses to regulator requests.
• Build and maintain productive working relationships with alliance partners, external companies, investigators, and key opinion leaders in support of clinical activities and collaborations.
• Contribute to manuscripts for scientific and medical journals and to presentations at scientific meetings.
• Additional duties assigned as needed.

Ausbildung

PhD/MD/PharmD

Jobbeschreibung

Travere Therapeutics, based in San Diego, seeks an Associate Director of Clinical Science to support ongoing and future clinical development. You will lead study design, data analyses, and regulatory submissions while coordinating cross-functional teams and ensuring adherence to GCP standards.

Ideal candidates hold a PhD/MD/PharmD with 4+ years in pharma, and have experience supporting clinical trials. Occasional domestic and international travel (up to 15%) is expected; some onsite work in San