Director, Clinical Science – Nephrology (Remote)

Travere Therapeutics; Denver (CO); Remote; USD 206,000 - 268,000; Full time

Job summary

Travere Therapeutics seeks a Director of Clinical Science to lead nephrology development programs, guide trial design and data analyses, and ensure adherence to GCPs. You will coordinate with cross-functional teams and prepare regulatory submissions and scientific communications.

The role requires advanced medical degree and substantial pharma industry experience, plus ability to travel. Join a team advancing therapies for rare diseases.

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.
• Contribute to clinical, scientific, and mechanism of action portions of INDs, NDAs and 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.

Education

PhD/PharmD/MD in Life Sciences

Job description

Travere Therapeutics seeks a Director of Clinical Science to lead nephrology development programs, guide trial design and data analyses, and ensure adherence to GCPs. You will coordinate with cross-functional teams and prepare regulatory submissions and scientific communications.

The role requires advanced medical degree and substantial pharma industry experience, plus ability to travel. Join a team advancing therapies for rare diseases.