Note: The job is a remote job and is open to candidates in USA. Travere Therapeutics is a biopharmaceutical company focused on developing and delivering therapies for people living with rare diseases. The Director, Clinical Science will support nephrology clinical development and lifecycle activities, including clinical trial design and execution, data analysis, regulatory documentation, and scientific presentations while ensuring Good Clinical Practices are followed.
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
- PhD, PharmD, and/or MD in 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
- Strong organizational abilities, high attention to detail, and excellent presentation skills
- Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
- Demonstrated ability to review, interpret and present complex scientific data
- Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment
- Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity
- Strong interpersonal and outstanding verbal and written communication skills are required
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
- 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
Benefits
- Premium health, financial, work-life and well-being offerings for eligible employees and dependents
- Wellness and employee support programs
- Life insurance
- Disability insurance
- Retirement plans with employer match
- Generous paid time off
- Short-term incentive
- Long-term incentive compensation (company stock)
Company Overview
Company H1B Sponsorship