Associate Director, Clinical Scientist

Travere; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Travere Therapeutics seeks an Associate Director, Clinical Science, to drive clinical trial design, data analyses, and regulatory submissions across rare disease programs.

You will lead cross-functional study teams, ensure GCP compliance, and contribute to INDs/NDAs/BLAs, with travel up to 15% and a strong commitment to patients and scientific excellence.

Qualifications

• PhD, PharmD, or MD in life sciences required.
• 4+ years of pharmaceutical industry experience; rare disease preferred.
• Experience supporting clinical trials and studies; human pharmacology background preferred.

Responsibilities

• Lead clinical science components of study plans and protocol design.
• Review and summarize clinical trial safety and efficacy data with the team.
• Coordinate timelines and deliverables across study teams with documentation.
• Support study conduct in accordance with GCP and regulations.
• Prepare and review clinical and data analysis reports and regulatory summaries.
• Contribute to INDs, NDAs, BLAs and related submissions with partners.
• Build relationships with alliance partners and key opinion leaders.
• Contribute to manuscripts and scientific presentations.

Skills

Clinical trial design

Data analysis

Regulatory submissions

Cross-functional collaboration

GCP compliance

Education

PhD, PharmD, or MD

Job description

Department: 106750 Clinical Development

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 Associate Director, Clinical Science, supports Travere's ongoing and future clinical development and life-cycle activities. Working with cross-functional study teams, this role contributes to clinical trial design and execution, translational and clinical data analyses, and the interpretation and presentation of results. The Associate Director coordinates assigned clinical science deliverables and helps ensure that studies are conducted in accordance with Good Clinical Practice (GCP).

Responsibilities:

• Lead clinical science components of assigned study plans and contribute to protocol design and implementation, including human pharmacology studies, and associated data analyses.
• Review, interpret, summarize clinical trial safety and efficacy data; identify findings and questions for discussion with the clinical development team.
• Coordinate assigned clinical science activities, timelines, and deliverables across study teams, maintaining accurate and well-organized documentation.
• Support study conduct in accordance with protocols, applicable regulations, and Good Clinical Practice (GCP).
• Lead the preparation and scientific review of clinical and data analysis reports, slide presentations, and ClinicalTrials.gov summaries in collaboration with clinical development, clinical pharmacology, statistics, and internal and external partners.
• Contribute clinical, scientific, and mechanism-of-action content to INDs, NDAs, BLAs, and related submissions, including protocols, statistical analysis plans, mock tables, figures, and listings, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit-risk assessments, regulatory briefing books, and responses to regulator requests.
• Build and maintain productive working relationships and represent the clinical science team with alliance partners, external companies, investigators, and key opinion leaders in support of assigned clinical activities and collaborations.
• Contribute to manuscripts for scientific and medical journals and to presentations at scientific meetings.
• Additional duties assigned as needed.

Education/Experience Requirements:

PhD, PharmD, or MD in a related life science discipline required. Equivalent combination of education and applicable job experience may be considered.

4+ years of relevant experience in the pharmaceutical industry required; experience in rare disease preferred.

Experience supporting clinical trials and clinical studies required; experience with human pharmacology studies preferred.

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.
• Experience contributing to INDs, NDAs, BLAs, or regulatory information requests preferred.
• Experience across range of development phases.
• Ability to collaborate effectively in multidisciplinary teams and contribute to respectful, open discussion and creative problem solving.
• Ability to review, interpret, summarize, and present complex scientific and clinical data.
• Strong organizational skills and ability to prioritize multiple responsibilities in a dynamic, cross-functional environment.
• Attention to detail and ability to follow through on assigned work while managing changes in scope or timelines.
• Strong interpersonal, written, and verbal communication skills.
• Flexibility to adapt to changes in project plans and implement agreed strategies and tactics.
• Self-motivated and can independently manage responsibilities.
• Ability to travel domestically and internationally as needed (up to 15%).

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 ex