Director, Clinical Pharmacology

Travere Therapeutics; Wichita (KS); Sur place; USD 189 000 - 246 000; Plein temps

Résumé du poste

Travere Therapeutics in San Diego seeks a Director of Clinical Pharmacology to lead PK/PD strategies across clinical programs. You will translate complex data into program decisions, guiding senior management and regulatory interactions.

The role requires a PhD/PharmD in Clinical Pharmacology with 6+ years in pharma/biotech development, strong PK/PD, and leadership in multidisciplinary teams. On-site in San Diego; travel up to 10% domestically and internationally.

Qualifications

• PhD or PharmD in Clinical Pharmacology is required.
• Demonstrated leadership in PK/PD and pharmacometrics across projects.
• Experience leading cross-functional teams and influencing decisions.

Responsabilités

• Lead clinical pharmacology strategy and integrate PK/PD and DDI across development stages.
• Provide strategic guidance to project teams on dose, design and evidence needs.
• Design and oversee PK/PD studies and modeling for early candidates.
• Support regulatory submissions with clinical pharmacology content.
• Review protocols and reports for regulatory filings and preempt questions.
• Authorship of protocols, Investigator's Brochures, and Clinical Study Reports.
• Build partnerships with R&D functions to align plans with program needs.
• Provide leadership at key milestones and portfolio decisions.

Connaissances

Strategic leadership

Pharmacology expertise

Cross-functional collaboration

Communication

Project leadership

Regulatory strategy

Formation

PhD or PharmD in Clinical Pharmacology

Outils

PK/PD modeling

Description du poste

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 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.
• Contributes to and helps advance the Clinical Pharmacology function, capabilities, and practices.
• Experience applying model‑informed drug development (MIDD) strategies across development phases and addressing questions on dose and regimen justification, labeling, and study design.

Additional Skills/Experience/Requirements:

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a small, fast-moving and 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 can independently manage responsibilities.
• Ability to travel 10% domestically and internationally.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

At Travere, we foster an environment where everyone can wear 'multiple hats' depending on their experience fit and motivation to get things done. We constantly strive to celebrate our achievements collectively and gather feedback to continuously sustain and improve our fast-paced cross-functional work environment.

Total Rewards Offerings:

Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people‑centric, and pay-for-performance organization.

Benefits:

Our benefits include premium health, financial, work‑life and well‑being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation:

Our competitive compensation package includes a combination of both cash compensation (base pay and short‑term incentive) and long‑term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range:

$189,000.00 - $246,000.00

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.