Director, Clinical Pharmacology at Travere Therapeutics in San Diego, CA

Job description

Department: 107600 Clinical Pharmacology Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients . Position Summary: The Director, Clinical Pharmacology will lead the design, development, and execution of clinical pharmacology strategies across Travere’s clinical programs. This role will shape and communicate clinical pharmacology recommendations to senior management, regulatory agencies, and external scientific peers, and translate complex data into clear implications for program strategy and development decisions. The individual will serve as a senior clinical pharmacology partner across functions, align recommendations with broader business and development objectives, and provide leadership at key decision points across the portfolio. 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. Education/Experience Requirements: PhD or PharmD in Clinical Pharmacology, Pharmaceutical Sciences, or a 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