Director, Clinical Science

Department:

106750 Clinical Development

Location:

San Diego, USA- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

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 verb