Director, Clinical Pharmacology
About The Position
The Director, Clinical Pharmacology will lead the design, development, and execution of clinical pharmacology strategies across Travere’s clinical programs. The role shapes and communicates clinical pharmacology recommendations to senior management, regulatory agencies, and external scientific peers, translating complex data into implications for program strategy and development decisions. The Director serves as a senior clinical pharmacology partner across functions, aligning recommendations with broader business and development objectives and providing leadership at key portfolio decision points. The role leads clinical pharmacology strategy and its integration into clinical development plans, including pharmacokinetics, pharmacodynamics, drug-drug interaction assessments, and model-informed drug development. It provides strategic guidance to clinical-stage project teams on dose, regimen, study design, and evidence needs; oversees clinical pharmacology studies; and leads clinical pharmacology content for regulatory submissions and development documents. The Director partners with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions. The position is listed as San Diego, USA—Remote, but all positions require the ability to perform face-to-face work with colleagues and/or onsite in San Diego; no role is expected to be 100% remote. Travel of 10% domestically and internationally is required.
Requirements
- PhD or PharmD in Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline.
- 6+ years of relevant clinical pharmacology experience in pharmaceutical or biotechnology development, or an equivalent drug-development setting.
- Clinical pharmacology expertise in one or more therapeutic areas, integrating evidence across multiple development phases and partnering across relevant scientific disciplines.
- 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.
- Experience applying model-informed drug development strategies across development phases and addressing dose and regimen justification, labeling, and study design.
- Ability to work effectively in a multidisciplinary team and foster an inclusive environment of respectful, open, and honest dialogue, idea sharing, and creative problem solving.
- Well organized, with the ability to multitask, prioritize, and manage shifting responsibilities in a small, fast-moving, entrepreneurial environment.
- Demonstrated ability to review, interpret, and present complex scientific data.
- Excellent communication, collaboration, and project leadership skills.
- Ability to manage multiple complex tasks with competing timelines.
- Self-motivated and able to independently manage responsibilities.
- Ability to travel 10% domestically and internationally.
Nice To Haves
- Alignment with Travere’s core values: Courage, Community Spirit, Patient Focus, and Teamwork.
- Driven, intelligent, and passionate about making a difference for patients with rare diseases.
Responsibilities
- Lead clinical pharmacology strategy and integrate pharmacokinetics, pharmacodynamics, and drug-drug interaction assessments into clinical development plans across development stages.
- Serve as the senior Clinical Pharmacology representative and provide strategic guidance to clinical-stage project teams on dose, regimen, study design, and evidence needs.
- Lead and oversee design and implementation of clinical pharmacology studies, including dose escalation, PK/PD assessments, and modeling for early drug candidates.
- Lead 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 development and independently author appropriate clinical pharmacology documents or sections, including clinical protocols, Investigator’s Brochures, and Clinical Study Reports.
- Build 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.
- Provide scientific and cross-functional project leadership, including scope management, progress tracking, risk identification, and delivery against timelines.
- Contribute to and help advance the Clinical Pharmacology function, its capabilities, and practices.
- Travel 10% domestically and internationally.
- Perform face-to-face work with colleagues and/or onsite in San Diego as needed.
Benefits
- Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
- Wellness and employee support programs.
- Life insurance and disability coverage.
- Retirement plans with employer match.
- Generous paid time off.
- Base pay and short-term incentive cash compensation.
- Long-term incentive compensation in company stock.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
