Associate Director, Clinical Scientist

Travere Therapeutics; Denver (CO); Teletrabalho; USD 150 000 - 195 000; Tempo integral

Resumo da oferta

Travere Therapeutics seeks an Associate Director of Clinical Science to support ongoing and future clinical development. You will collaborate with cross-functional study teams on trial design, data analyses, and regulatory documentation, ensuring adherence to GCP.

The role requires advanced scientific training and 4+ years in pharma, with experience in rare disease and IND/ NDA submissions, plus ability to travel up to 15%. This position is based in San Diego with some remote flexibility.

Qualificações

• 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.

Responsabilidades

• Lead clinical science components of assigned study plans and contribute to protocol design and implementation.
• 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 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.
• Contribute to manuscripts for scientific and medical journals and to presentations at scientific meetings.
• Additional duties assigned as needed.

Conhecimentos

Cross-functional collaboration

Data interpretation & presentation

Scientific writing

Attention to detail

Formação académica

PhD/PharmD/MD in life sciences

Descrição da oferta de emprego

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 expected to be 100% remote.

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

$150,000.00 - $195,000.00

*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.