Director, Clinical Science – Nephrology & Rare Diseases

Travere Therapeutics; Columbus (OH); Teletrabalho; USD 206 000 - 268 000; Tempo integral

Resumo da oferta

Travere Therapeutics, in San Diego with a remote work model, is seeking a Director, Clinical Science to lead nephrology development and lifecycle activities. You will oversee multidisciplinary trial design, data analyses, and reporting in alignment with Good Clinical Practices.

The role requires collaboration across clinical development and pharmacology teams, with responsibilities for INDs, NDAs, BLAs, and regulatory documents. Travel up to 15% domestically and internationally may be required.

Qualificações

• PhD, PharmD, and/or MD in related Life Science discipline required; experience in rare disease and/or nephrology preferred.
• 6 years of experience in the pharmaceutical industry; equivalent combination of education and applicable job experience may be considered.
• Experience working on clinical trials and clinical studies required; experience with human pharmacology studies preferred.
• Experience contributing to INDs, NDAs, BLAs, and regulatory information requests strongly preferred.

Responsabilidades

• Assist in design and implementation of clinical studies (including human pharmacology studies) and data analyses.
• Assist in reporting clinical trial data for safety and efficacy.
• Collaborate with team members to ensure Good Clinical Practices (GCPs) are followed.
• Leadership position for writing clinical and data analysis reports, slide presentations, clinicaltrial.gov summaries, etc. with other clinical development and clinical pharmacology team members, internal and external collaborators, and statistical staff.
• Contribute to clinical, scientific, and mechanism of action portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, SAPs, mock TFLs, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk ratios, regulatory briefing books, and responding to information requests from regulators.
• Establish and maintain relationships with alliance partners, external companies, investigators, and key opinion leaders to optimize performance on clinical activities and collaborations.
• Prepare manuscripts for scientific and medical journals as well as prepare and present at scientific meetings.

Conhecimentos

Leadership

Data analysis

Clinical trial design

Cross-functional collaboration

Formação académica

PhD/PharmD/MD

Descrição da oferta de emprego

Travere Therapeutics, in San Diego with a remote work model, is seeking a Director, Clinical Science to lead nephrology development and lifecycle activities. You will oversee multidisciplinary trial design, data analyses, and reporting in alignment with Good Clinical Practices.

The role requires collaboration across clinical development and pharmacology teams, with responsibilities for INDs, NDAs, BLAs, and regulatory documents. Travel up to 15% domestically and internationally may be required.