Director, Clinical Science

🔥 13 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $206k - $268k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 0%

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Travere Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Travere Therapeutics is a biopharmaceutical company committed to identifying, developing, and delivering life-changing therapies for people living with rare diseases, particularly those related to rare kidney and metabolic disorders. The company has a strong focus on advancing science in these fields, with a pipeline that includes treatments for conditions such as IgA nephropathy and focal segmental glomerulosclerosis. With the full U. S. FDA approval of its non-immunosuppressive treatment for IgA nephropathy, Travere Therapeutics continues to set new standards of care. The company collaborates with the rare kidney disease community, including patient advocacy organizations and clinical trial investigators, to bring hope to patients with these serious conditions.

📋 Description

• Provide management and support for ongoing and future nephrology development and life-cycle activities for clinical programs • Assist in the design and implementation of clinical studies, including human pharmacology studies, and data analyses • Assist in reporting clinical trial safety and efficacy data • Collaborate with cross-functional multidisciplinary study teams to ensure Good Clinical Practices are followed • Lead writing of clinical and data analysis reports, slide presentations, ClinicalTrials.gov summaries, and related materials • Contribute to clinical, scientific, and mechanism-of-action sections of INDs, NDAs, and BLAs • Prepare protocols, SAPs, mock TFLs, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk ratios, regulatory briefing books, and responses to regulator information requests • Establish and maintain relationships with alliance partners, external companies, investigators, and key opinion leaders • Prepare manuscripts for scientific and medical journals • Prepare and present at scientific meetings

🎯 Requirements

• PhD, PharmD, and/or MD in a related Life Science discipline required • 6 years of experience in the pharmaceutical industry; equivalent combination of education and applicable job experience in academic or other setting may be considered • Experience working on clinical trials and clinical studies required • Experience in rare disease and/or nephrology preferred • Experience with human pharmacology studies preferred • Experience contributing to INDs, NDAs, BLAs, and regulatory information requests strongly preferred • Strong organizational abilities and high attention to detail • Excellent presentation skills • Ability to work effectively in a multidisciplinary team • Demonstrated ability to review, interpret, and present complex scientific data • Ability to multitask, prioritize, and manage shifting responsibilities • Strong interpersonal and outstanding verbal and written communication skills • Ability to adapt to project plan modifications and changes • Ability to travel 15% domestically and internationally

🏖️ Benefits

• Premium health, financial, work-life and well-being offerings for eligible employees and dependents • Wellness and employee support programs • Life insurance • Disability coverage • Retirement plans with employer match • Generous paid time off • Short-term incentive compensation • Long-term incentive compensation through company stock