Director, Clinical Science

Travere Therapeutics; Washington (District of Columbia); Remote; USD 206,000 - 268,000; Full time

Benefits offered by this job

Premium health benefits

Well-being programs

Retirement plan with employer match

Generous paid time off

Job summary

Travere Therapeutics in San Diego invites a Director, Clinical Science to lead nephrology development across programs. You will collaborate with cross-functional teams on trial design, data analyses, and regulatory readiness, ensuring GCPs are followed and data are presented clearly.

Requirements include a PhD, PharmD, or MD in life sciences, 6+ years in pharma, and experience with INDs/NDAs/BLAs. You will write clinical reports, contribute to regulatory submissions, build external partnerships,

Qualifications

• PhD, PharmD or MD in life sciences with relevant rare disease nephrology experience.
• 6+ years in the pharmaceutical industry or equivalent experience in academia or industry.
• Experience with INDs, NDAs, BLAs and regulatory information requests preferred.

Responsibilities

• Design and implement clinical studies and data analyses.
• Report clinical trial data for safety and efficacy with team collaboration.
• Ensure GCP compliance across studies and data handling.
• Lead writing of clinical and data analysis reports and regulatory documents.
• Build and maintain external alliances to optimize collaborations.
• Prepare manuscripts and present findings at scientific meetings.

Skills

Clinical trial design

Data analysis

GCP compliance

Regulatory submissions

Cross-functional leadership

Presentation skills

Education

PhD, PharmD, or MD in Life Sciences

6+ years pharma industry experience

Job description

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 as well as related translational and clinical data analyses, interpretation, and presentation of data while ensuring that Good Clinical Practices (GCPs) 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.

Education/Experience Requirements

• 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 in academic or other setting 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.

Additional Skills/Experience

• Strong organizational abilities, high attention to detail, and excellent presentation skills.
• 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 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.
• Ability to travel 15% domestically and internationally.

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:

$206,000.00 - $268,000.00

*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 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 [e-mail]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.