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Travere Therapeutics

Develops and commercializes rare-disease therapies

Director, Clinical Science

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A PhD, PharmD, and/or MD in a related Life Science discipline is required.
  • Six years of experience in the pharmaceutical industry; an equivalent combination of education and applicable job experience in an academic or other setting may be considered.
  • Experience working on clinical trials and clinical studies is required.
  • Strong organizational abilities, high attention to detail, and presentation skills are required.
  • Ability to work effectively in a multidisciplinary team and foster respectful, open, and honest dialogue and sharing of ideas and creative problem solving.
  • Demonstrated ability to review, interpret, and present complex scientific data.
  • Ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional environment.
  • Strong interpersonal, verbal communication, and written communication skills are required.
  • Ability to adapt to modifications and changes to project plans and implement new strategies and tactics.
  • Ability to travel 15% domestically and internationally.

Responsibilities

  • Assist in the design and implementation of clinical studies, including human pharmacology studies, and data analyses.
  • Assist in reporting clinical trial safety and efficacy data.
  • Collaborate with team members to ensure Good Clinical Practices are followed.
  • Lead writing clinical and data analysis reports, slide presentations, clinicaltrials.gov summaries, and related materials with clinical development and clinical pharmacology team members, internal and external collaborators, and statistical staff.
  • Contribute to clinical, scientific, and mechanism-of-action portions of Investigational New Drug applications, New Drug Applications, and Biologics License Applications, including protocols, statistical analysis plans, mock tables, figures and listings, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk ratios, regulatory briefing books, and responses to regulator information requests.
  • Establish and maintain relationships with alliance partners, external companies, investigators, and key opinion leaders to optimize clinical activities and collaborations.
  • Prepare manuscripts for scientific and medical journals and prepare and present at scientific meetings.

Desired Qualifications

  • Experience in rare disease and/or nephrology.
  • Experience with human pharmacology studies.
  • Experience contributing to Investigational New Drug applications, New Drug Applications, Biologics License Applications, and regulatory information requests.

About the Company

Travere Therapeutics

Develops and commercializes rare-disease therapies

Travere Therapeutics develops and commercializes therapies for rare diseases, especially kidney and metabolic disorders. It has commercial products Thiola and Thiola EC for cystinuria and Chenodal for gallstones, with a pipeline that includes sparsentan for focal segmental glomerulosclerosis and IgA nephropathy. The company generates revenue from the sale of its products and supports patients through a dedicated patient assistance program. Its approach centers on identifying and delivering treatments for rare diseases, combining commercialization with ongoing drug development.

Company size
501-1,000
Company stage
IPO
Headquarters
San Diego, CA
Founded
2008

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