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Director, Clinical Science

TravereSan Diego, CA, US

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Position Summary

The Director, Clinical Science, will provide management and support for Travere's on-going and future nephrology development and life-cycle activities for clinical programs. The position will work with cross-functional multidisciplinary study teams on clinical trial design and execution (i.e. support development of protocol synopsis, clinical protocols, investigator brochures, SAPs, mock TFLs, regulatory briefing books, responses to regulatory information requests), as well as related translational and clinical data analyses, interpretation, and presentation of data while ensuring that Good Clinical Practices (GCPs) are followed.

Responsibilities

Data management, analyses, interpretation, and presentation activities working closely with internal team members as well as external investigators / collaborators.
Assist in design and implementation of clinical studies and clinical and / or translational data analyses.
Assist in reporting clinical trial data for safety and efficacy.
Strong ability to organize and excellent presentation skills.
Ensures that Good Clinical Practices (GCPs) are followed.
Leader for writing clinical and data analysis reports, investigator brochures, clinicaltrial.gov summaries, etc. with other clinical development team members, 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, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit / risk ratios, 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 / Experience Requirements

Ph.D, Pharm D, and / or MD in related Life Science discipline required. Equivalent combination of education and applicable job experience may be considered.

Bioinformatics-related experience pertaining to the components of biological knowledge, database design and management, statistical knowledge, programming, and data mining / machine learning strongly preferred.

Minimum 6-8 years of experience in the pharmaceutical industry.

Experience working on clinical trials preferred.

Experience contributing to INDs, NDAs, BLAs preferred

Additional Skills / Experience

Driven, intelligent, passionate about making a difference for patients with rare diseases. 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 organizational skills and excellent 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.

Ability to travel domestically and internationally as needed (up to 15%).

Total Rewards Offerings : Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.

Benefits : Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation : Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range : $181,000.00 - $235,000.00

This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

Travere Therapeutics, Inc. is an EEO / AA / Veteran / Disability Employer.

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only.

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Director Clinical • San Diego, CA, US