Senior Director, Clinical Pharmacology — Rare-Disease Impact (Remote)

Travere Therapeutics

Minneapolis (MN)

On-site

USD 189,000 - 246,000

Full time

8 days ago

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Benefits offered by this job

Premium health
Well-being programs
Retirement plan
Generous paid time off

Job summary

Travere Therapeutics seeks a Director, Clinical Pharmacology to lead the design, development, and execution of pharmacology strategies across clinical programs in a fast-paced setting. You will translate data into actionable program decisions and serve as a senior pharmacology partner to Regulatory and Project Management.

You will oversee PK/PD studies, dosing decisions, and contribute to regulatory submissions (INDs, CTAs, NDAs) while mentoring teams and guiding strategic decisions at key

Qualifications

  • PhD or PharmD with 6+ years of clinical pharmacology experience in pharma/biotech development.
  • Experience in PK/PD, biopharmaceutics, and pharmacometrics across multiple projects.
  • Leadership in cross-functional teams and project management.
  • Experience applying model-informed drug development (MIDD) strategies.

Responsibilities

  • Lead clinical pharmacology strategy and integration into development plans, including PK/PD and DDI assessments.
  • Serve as senior Clinical Pharmacology representative and guide project teams on dose, regimen, study design, and evidence needs.
  • Oversee design and implementation of clinical pharmacology studies for early candidates with appropriate dosing strategies.
  • Support regulatory submissions including briefing documents, INDs, CTAs, and NDAs.
  • Review protocols and reports for filings, anticipate regulatory questions.
  • Develop and author clinical pharmacology documents (e.g., protocols, Investigator's Brochures, Study Reports).
  • Build partnerships with Research, Bioanalytical, Clinical, Regulatory, PM and other R&D functions.
  • Provide timely, decision-focused pharmacology leadership at milestones.

Skills

Clinical pharmacology expertise
Cross-functional leadership
Strategic communication
PK/PD & modeling

Education

PhD or PharmD in Clinical Pharmacology or related

Job description

Travere Therapeutics seeks a Director, Clinical Pharmacology to lead the design, development, and execution of pharmacology strategies across clinical programs in a fast-paced setting. You will translate data into actionable program decisions and serve as a senior pharmacology partner to Regulatory and Project Management.

You will oversee PK/PD studies, dosing decisions, and contribute to regulatory submissions (INDs, CTAs, NDAs) while mentoring teams and guiding strategic decisions at key

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