Senior Director, Clinical Pharmacology - Remote

Travere Therapeutics

Manchester (NH)

On-site

USD 189,000 - 246,000

Full time

8 days ago

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Benefits offered by this job

Premium health
Retirement plan with match

Job summary

Travere Therapeutics in San Diego is seeking a Director of Clinical Pharmacology to lead design, development, and execution of pharmacology strategies across clinical programs. You will shape recommendations for senior management, regulators, and peers, translating data into clear implications for strategy and development decisions.

You will partner with multiple R&D functions to ensure dosing, study design, and evidence needs align with program goals, and contribute to regulatory filings and

Qualifications

  • PhD or PharmD in Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline, with 6+ years of relevant clinical pharmacology experience.
  • Demonstrated clinical pharmacology expertise across therapeutic areas and development phases.
  • Experience leading PK/PD, biopharmaceutics, and pharmacometrics across projects.
  • Proven cross-functional project leadership and ability to influence decisions.
  • Experience applying model-informed drug development (MIDD) strategies across development phases.

Responsibilities

  • Lead clinical pharmacology strategy and its integration into clinical development plans, including PK/PD and DDI assessments.
  • Serve as senior Clinical Pharmacology representative and provide strategic guidance on dose, regimen, study design, and evidence needs.
  • Oversee design and implementation of clinical pharmacology studies (e.g., dose escalation, PK/PD modeling) for early candidates.
  • Lead regulatory submission content, including briefing documents, INDs, CTAs, and NDAs.
  • Review protocols and reports for regulatory filings and prepare responses to regulatory questions.
  • Develop and author clinical pharmacology documents (protocols, Investigator's Brochures, CSRs).
  • Build partnerships with Research, Regulatory, and other R&D functions to align pharmacology plans with program needs.
  • Provide timely, decision-focused pharmacology leadership at milestones and portfolio decisions.

Skills

Clinical pharmacology
PK/PD expertise
Regulatory strategy
Cross-functional leadership
MIDD experience

Education

PhD or PharmD

Job description

Travere Therapeutics in San Diego is seeking a Director of Clinical Pharmacology to lead design, development, and execution of pharmacology strategies across clinical programs. You will shape recommendations for senior management, regulators, and peers, translating data into clear implications for strategy and development decisions.

You will partner with multiple R&D functions to ensure dosing, study design, and evidence needs align with program goals, and contribute to regulatory filings and

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