Director, Clinical Pharmacology

Travere • San Diego, CA

5d • Remote

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 recommendations to senior management, regulatory agencies, and external scientific peers, translating complex data into implications for program strategy and development decisions. As a senior clinical pharmacology partner across functions, the Director aligns recommendations with business and development objectives and provides leadership at key portfolio decision points.

The role leads clinical pharmacology strategy and its integration into clinical development plans, including pharmacokinetic, pharmacodynamic, and drug-drug interaction assessments throughout development. It provides strategic guidance to clinical-stage project teams on dose, regimen, study design, and evidence needs; oversees clinical pharmacology study design and implementation; and leads clinical pharmacology content for regulatory submissions. The Director also reviews protocols and scientific reports, authors clinical pharmacology documents, and partners with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions.

The position is listed as remote in San Diego, but the posting states that roles are not expected to be 100% remote and require face-to-face work with colleagues and/or onsite work in San Diego. Travel of 10% domestically and internationally is required.

Requirements

• PhD or PharmD in Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline.
• At least 6 years of relevant clinical pharmacology experience in pharmaceutical or biotechnology development, or an equivalent drug-development setting.
• Demonstrated clinical pharmacology expertise in one or more therapeutic areas and experience integrating evidence across multiple development phases and partnering across 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.
• Experience applying model-informed drug development (MIDD) strategies across development phases and addressing questions on dose and regimen justification, labeling, and study design.
• Ability to work effectively in a multidisciplinary team and foster respectful, open, and honest dialogue, idea sharing, and creative problem solving.
• 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; well organized and able to prioritize shifting responsibilities.
• Self-motivated and able to independently manage responsibilities.
• Ability to perform face-to-face work with colleagues and/or work onsite in San Diego.

Nice To Haves

• Driven, intelligent, and passionate about making a difference for patients with rare diseases.
• Embodies Travere’s core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• Able to thrive in a small, fast-moving, entrepreneurial environment.

Responsibilities

• Lead clinical pharmacology strategy and integrate it into clinical development plans, incorporating pharmacokinetics, pharmacodynamics, and drug-drug interaction assessments across development stages.
• Serve as senior Clinical Pharmacology representative and provide strategic guidance to clinical-stage project teams on dose, regimen, study design, and evidence needs.
• Lead and oversee the 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 provide independent authorship of appropriate clinical pharmacology documents or sections, including clinical protocols, Investigator’s Brochures, and Clinical Study Reports.
• Partner 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 development milestones and portfolio decision points.
• Contribute to and help advance the Clinical Pharmacology function, capabilities, and practices.
• Travel 10% domestically and internationally.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance.
• Disability benefits.
• Retirement plans with employer match.
• Generous paid time off.
• Cash compensation consisting of base pay and short-term incentive.
• Long-term incentive compensation in company stock.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree