Senior Director, Clinical Science – Nephrology & Rare Disease

Travere Therapeutics; New York (NY); Remote; USD 206,000 - 268,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Stock options

Job summary

Travere Therapeutics is seeking a Director of Clinical Science to lead nephrology development activities, trial design, data interpretation and regulatory coordination. You will work with cross-functional teams to ensure GCP adherence and rigorous data analysis across programs.

The role emphasizes collaboration with external partners, manuscript preparation, and leadership in regulatory documentation including INDs, NDAs, and BLAs, while supporting strategic development and scientific

Qualifications

• 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.

Responsibilities

• 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.

Skills

Clinical trial design

Data analysis

Good Clinical Practices (GCPs)

Manuscript writing

Regulatory submissions (INDs/NDAs/BLAs

Education

PhD/MD/PharmD in Life Sciences

Job description

Travere Therapeutics is seeking a Director of Clinical Science to lead nephrology development activities, trial design, data interpretation and regulatory coordination. You will work with cross-functional teams to ensure GCP adherence and rigorous data analysis across programs.

The role emphasizes collaboration with external partners, manuscript preparation, and leadership in regulatory documentation including INDs, NDAs, and BLAs, while supporting strategic development and scientific