Manager, REMS and Clinical Operations

Department:

Location:

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 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 Manager REMS & Clinical Operations is responsible for the execution management and oversight of Risk Evaluation and Mitigation Strategies (REMS) programs while also supporting select clinical operations activities across Phase 13 clinical trials. This role translates REMS strategy into execution ensuring regulatory compliance operational excellence and delivery of program parallel the role contributes to clinical study execution through vendor oversight cross-functional leadership and management of key operational activities.

Key Responsibilities REMS Program Management:

• Lead day-to-day management and execution of REMS programs ensuring alignment with regulatory requirements and corporate objectives.
• Own operational timelines deliverables and milestones for REMS programs proactively identifying risks and implementing mitigation strategies.
• Serve as a primary point of contact for internal cross-functional teams and support external stakeholder interactions related to REMS operations.
• Oversee REMS Administrator/vendor activities including deliverables performance management and issue resolution support contract and budget tracking.
• Author review and approve REMS-related documentation including procedures workflows training materials and assessment report components.
• Lead tracking analysis and reporting of REMS program metrics compliance data and key performance indicators.
• Establish and manage processes for identifying documenting and reporting stakeholder noncompliance.
• Support and lead elements of audit and inspection readiness including documentation SME participation and response coordination.
• Oversee data collection validation and reporting to ensure accuracy and regulatory compliance.
• Participate in and/or lead adverse event case review activities as required.
• Identify and drive continuous improvement initiatives across REMS processes systems and vendor operations.
• Monitor regulatory landscape for REMS-related changes and assess operational impact escalating strategic considerations as appropriate.

Key Responsibilities Clinical Operations Support:

• Manage and provide daily oversight of internal study teams full-service CROs clinical sites and third-party vendors to ensure successful clinical trial implementation and execution.
• Track study progress (e.g. timelines enrollment deliverables) and escalate risks or delays.
• Assist in the development and review of study documents and operational plans (e.g. protocols study tools site materials).
• Contribute to study execution by facilitating cross-functional collaboration and resolving operational issues.
• Support vendor oversight and budget tracking for assigned clinical activities.
• Ensure study conduct aligns with GCP regulatory requirements and study plans.

Education/Experience Requirements:

• Bachelors degree or equivalent combination of education and applicable job experience may be considered.
• 6 years of experience in pharmaceutical biotechnology or CRO industry.
• 3-5 years of direct experience supporting REMS or similar risk management programs preferred.
• Experience in clinical trial operations (Phase 13) required or strongly preferred.
• Working knowledge of FDA regulations global clinical regulations and REMS requirements as well as ICH/GCP guidelines.

Additional Skills/Experience:

• The ideal candidate will embody Traveres core values: Courage Community Spirit Patient Focus and Teamwork.
• Strong project and program management skills with the ability to manage multiple priorities across REMS and clinical activities.
• Demonstrated ability to independently oversee vendors and manage external partnerships and proactively escalate risks or issues.
• Effective communication skills with ability to influence cross-functional teams.
• Proactive self-starter who possesses the desire to take on additional tasks (in and out Clinical Operations).
• Ability to establish goals for multiple priorities/assigned studies and can execute within an established timeframe with limited oversight.
• Ability to identify issues determine cause and propose solutions with limited oversight.
• Proficient communication skills both oral and written with ability to present study updates at various cross-functional meetings.
• Proficient problem-solving skills and critical thinking skills.
• Strong sense of urgency keen attention to detail and ability to work independently.
• Should have strong skills in MS Office and timeline software such as MS Project or with clinical systems such as IRT eTMF etc.
• Demonstrates excellent understanding of cross functional activities and input into clinical studies.
• Ability to travel 10-20% domestic and internationally.

Travere is an EEO/AA/Veteran/Disability Employer

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:

*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 candidates 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 . 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.