Senior Director, Clinical Pharmacology — Remote

Travere Therapeutics; Providence (RI); On-site; USD 189,000 - 246,000; Full time

Benefits offered by this job

Premium health

Retirement plan with employer match

Paid time off

Well-being offerings

Job summary

Travere Therapeutics is seeking a Director of Clinical Pharmacology in San Diego (onsite) to lead PK/PD strategy across clinical programs and guide regulatory interactions. You will translate complex data into actionable program decisions and partner with cross-functional teams to align pharmacology plans with development goals.

The role requires a PhD/ PharmD in Clinical Pharmacology with 6+ years of experience, strong leadership, and expertise in model-informed drug development.

Qualifications

• PhD or PharmD in Clinical Pharmacology, Pharmaceutical Sciences, or related discipline, with 6+ years of relevant clinical pharmacology experience in pharmaceutical/biotechnology development or an equivalent drug-development setting, required.
• Demonstrated clinical pharmacology expertise in one or more therapeutic areas, with experience integrating evidence across multiple development phases and partnering across relevant scientific disciplines.
• Demonstrated leadership in PK/PD, biopharmaceutics, and pharmacometrics across multiple projects, from strategy and planning through implementation, interpretation, and communication of results.
• Experience providing scientific and cross-functional project leadership, including influencing decisions across teams.
• Strong project leadership skills, including scope management, progress tracking, risk identification, and delivery against timelines.
• Contributes to and helps advance the Clinical Pharmacology function, capabilities, and practices.
• Experience applying model-informed drug development (MIDD) strategies across development phases and addressing questions on dose and regimen justification, labeling, and study design.

Responsibilities

• Lead clinical pharmacology strategy and its integration into clinical development plans by integrating pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction assessments across all stages of clinical development.
• Serve as the senior Clinical Pharmacology representative and provide strategic guidance to clinical-stage project teams, including recommendations on dose, regimen, study design, and evidence needs.
• Lead and oversee the design and implementation of clinical pharmacology studies (e.g., dose escalation and PK/PD assessments and modeling) for early drug candidates, ensuring appropriate dosing strategies and decision-quality evidence.
• Lead the clinical pharmacology strategy and content supporting regulatory submissions, including briefing documents, INDs, CTAs, and NDAs.
• Review clinical protocols and scientific reports for regulatory filings, identify potential gaps, and anticipate and prepare responses to regulatory questions.
• Lead the development and provide independent authorship of appropriate clinical pharmacology documents or sections, including clinical protocols, Investigator's Brochures, and Clinical Study Reports.
• Build strong partnerships with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions to align clinical pharmacology plans with program needs.
• Provide timely, decision-focused clinical pharmacology leadership at key development milestones and portfolio decision points.

Skills

PK/PD

Pharmacokinetics

Pharmacodynamics

MIDD

Regulatory strategy

Cross-functional leadership

Dose selection

IND/CTA/NDA experience

Education

PhD or PharmD in Clinical Pharmacology

Job description

Travere Therapeutics is seeking a Director of Clinical Pharmacology in San Diego (onsite) to lead PK/PD strategy across clinical programs and guide regulatory interactions. You will translate complex data into actionable program decisions and partner with cross-functional teams to align pharmacology plans with development goals.

The role requires a PhD/ PharmD in Clinical Pharmacology with 6+ years of experience, strong leadership, and expertise in model-informed drug development.