Associate Director, Clinical Scientist

Travere•San Diego, CA

4d•Hybrid

About The Position

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).

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.
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 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.

Nice To Haves

Experience contributing to INDs, NDAs, BLAs, or regulatory information requests preferred.
Experience across range of development phases.

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.