Director, Clinical Pharmacology — Remote PK/PD Leadership

Travere Therapeutics; Washington (District of Columbia); On-site; USD 189,000 - 246,000; Full time

Benefits offered by this job

Premium health

Financial benefits

Work-life and well-being

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics in San Diego, CA is seeking a Director, Clinical Pharmacology to lead PK/PD strategy across programs. You will translate complex data into actionable program decisions and partner with senior management and regulatory science teams.

You will guide dose justification, study design, and evidence needs, and drive model-informed drug development across development stages, collaborating with Regulatory, Clinical Operations, and Biostatistics.

Qualifications

• PhD or PharmD in Clinical Pharmacology or related field.
• 6+ years of clinical pharmacology experience in pharma/biotech.
• Experience influencing decisions across teams.
• Strong PK/PD, biopharmaceutics and pharmacometrics skills.
• Experience with model-informed drug development (MIDD).

Responsibilities

• Lead clinical pharmacology strategy and integrate PK/PD into development plans.
• Provide strategic guidance to cross-functional teams on dose, regimen, study design.
• Design and oversee clinical pharmacology studies and PK/PD modeling.
• Support regulatory submissions with briefing documents and NDAs/INDs.
• Review protocols and reports for regulatory filings and anticipate questions.
• Develop clinical pharmacology documents such as Investigator's Brochures and CSRs.
• Partner with R&D functions to align plans with program needs.
• Provide leadership at key milestones.

Skills

Clinical pharmacology

PK/PD

MIDD

Leadership

Cross-functional collaboration

Regulatory strategy

Education

PhD or PharmD in Clinical Pharmacology

Job description

Travere Therapeutics in San Diego, CA is seeking a Director, Clinical Pharmacology to lead PK/PD strategy across programs. You will translate complex data into actionable program decisions and partner with senior management and regulatory science teams.

You will guide dose justification, study design, and evidence needs, and drive model-informed drug development across development stages, collaborating with Regulatory, Clinical Operations, and Biostatistics.